key: cord-0318366-j8h0nafv authors: Charide, R.; Stallwood, L.; Munan, M.; Sayfi, S.; Hartling, L.; Butcher, N. J.; Offringa, M.; Elliott, S.; Richards, D. P.; Mathew, J. L.; Akl, E. A.; Kredo, T.; Motillal, A.; Baba, A.; Prebeg, M.; Relihan, J.; Scott, S. D.; Suvada, J.; Falavigna, M.; Klugar, M.; Lotfi, T.; Stevens, A.; Pottie, K.; Schünemann, H. J. title: Knowledge mobilization activities to support decision-making by youth, parents, and adults using a systematic and living map of evidence and recommendations on COVID-19: protocol for a randomized controlled trial date: 2022-05-10 journal: nan DOI: 10.1101/2022.05.09.22274842 sha: e1985a7a5227629cac8e5b870f5868d2e3284638 doc_id: 318366 cord_uid: j8h0nafv Introduction The COVID-19 pandemic underlined that guidelines and recommendations must be made more accessible and more understandable to the general public, including adults, parents, and youth, to improve health outcomes. The objective of this study is to the public's (youth, parents, and adult populations) understanding, usability, satisfaction, intention to implement, and preference for different ways of presenting COVID-19 health recommendations derived from the COVID-19 Living Map of Recommendations and Gateway to Contextualization (herein referred to as the RecMap). Methods and Analysis This is a protocol for a mixed-methods study. We will conduct a pragmatic allocation-concealed, blinded superiority randomized controlled trial (RCT) in three populations: adults (21 years of age or older), parents (18 years or above and are a parent or legal guardian of a child under 18 years old), and youth (15 to 24 years old), with at least 240 participants in each population. The trial will consist of an online survey and optional one on one interview. Prior to initiating the RCT, all PLRs were refined with relevant stakeholder input. In each population group, the intervention arm will receive a PLR format while the control arm will receive the original recommendation format as originally published by the guideline organizations (herein referred to as Standard Language Version). Our primary outcome is understanding, and our secondary outcomes are accessibility and usability, satisfaction, intended behavior, and preference for the two recommendation formats. Each population's results will be analyzed separately. We will pool the results across populations using meta-analysis, and also explore potential interaction and subgroup effects within each population. At the end of each survey, participants will be invited to participate in a one-on-one semi-structured interview to explore reasons for their choices and learn for future research. All interviews will be analyzed using thematic analysis. Interpretation will be iterative as data coding proceeds. Ethics and Dissemination Through Clinical Trials Ontario (CTO), the Hamilton Integrated Research Ethics Board has reviewed and approved this protocol (Project ID: 3856). The University of Alberta will also be submitting for ethics approval. All potential participants will be required to provide informed consent. The findings from this study will be disseminated through open-access publications in peer-reviewed journals. Strengths and limitations of this study {middle dot} We are following a mixed methods approach: randomized controlled trial and qualitative interviews. The qualitative results will supplement and help explain our quantitative findings. {middle dot} This protocol is reported in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), which enhances transparency and completeness. The trial uses previously validated outcomes from similar trials. This will strengthen the credibility of our results. {middle dot} Our study is testing an evaluated PLR format, which makes our intervention stronger, and is recruiting internationally, which ensures the inclusion of a diverse population. {middle dot} Recruitment will take place online using social media, and data will be collected using an online survey. This allows for self-selection and limits accessibility to those who have no or limited digital access, which in turn limits generalizability. {middle dot} While the recommendations are offered in multiple languages through the RecMap, the study is only testing English Plain Language Recommendations. The COVID-19 pandemic underlined that guidelines and recommendations must be made more accessible and more understandable to the general public, including adults, parents, and youth, to improve health outcomes. The objective of this study is to the public's (youth, parents, and adult populations) understanding, usability, satisfaction, intention to implement, and preference for different ways of presenting COVID-19 health recommendations derived from the COVID-19 Living Map of Recommendations and Gateway to Contextualization (herein referred to as the RecMap). This is a protocol for a mixed-methods study. We will conduct a pragmatic allocationconcealed, blinded superiority randomized controlled trial (RCT) in three populations: adults (21 years of age or older), parents (18 years or above and are a parent or legal guardian of a child under 18 years old), and youth (15 to 24 years old), with at least 240 participants in each population. The trial will consist of an online survey and optional one on one interview. Prior to initiating the RCT, all PLRs were refined with relevant stakeholder input. In each population group, the intervention arm will receive a PLR format while the control arm will receive the original recommendation format as originally published by the guideline organizations (herein referred to as Standard Language Version). Our primary outcome is understanding, and our secondary outcomes are accessibility and usability, satisfaction, intended behavior, and preference for the two recommendation formats. Each population's results will be analyzed separately. We will pool the results across populations using meta-analysis, and also explore potential interaction and subgroup effects within each population. At the end of each survey, participants will be invited to participate in a one-on-one semi-structured interview to explore reasons for their choices and learn for future research. All interviews will be analyzed using thematic analysis. Interpretation will be iterative as data coding proceeds. Through Clinical Trials Ontario (CTO), the Hamilton Integrated Research Ethics Board has reviewed and approved this protocol (Project ID: 3856). The University of Alberta will also be submitting for ethics approval. All potential participants will be required to provide informed consent. The findings from this study will be disseminated through open-access publications in peer-reviewed journals. • We are following a mixed methods approach: randomized controlled trial and qualitative interviews. The qualitative results will supplement and help explain our quantitative findings. • This protocol is reported in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT), which enhances transparency and completeness. The trial uses previously validated outcomes from similar trials. This will strengthen the credibility of our results. • Our study is testing an evaluated PLR format, which makes our intervention stronger, and is recruiting internationally, which ensures the inclusion of a diverse population. • Recruitment will take place online using social media, and data will be collected using an online survey. This allows for self-selection and limits accessibility to those who have no or limited digital access, which in turn limits generalizability. • While the recommendations are offered in multiple languages through the RecMap, the study is only testing English Plain Language Recommendations. As clinicians, policymakers, and the public are inundated with information, misinformation, and health recommendations about COVID-19, we have built a unique repository of trustworthy COVID-19 recommendations with funding from the Canadian Institutes of Health Research (CIHR) (covid19.recmap.org). The overarching goal of this COVID-19 RecMap effort is to identify all COVID-19 guidelines, assess their credibility and trustworthiness, and make their recommendations available and understandable to various stakeholder groups [1] . To enhance understanding of health recommendations, we developed a process to draft, edit, and publish plain language recommendations (PLRs) [2] . Until now, plain language versions of recommendations have been poorly explored, and our work on the RecMap indicates an absence of this critical Knowledge Mobilization tool for the general public, including youth, adults, and parents [3] . Existing trials on tailored PLR presentations have been small and predated recent guidance on how to present guideline recommendations, targeted health professionals, or did not target the general public [4] [5] [6] [7] . For example, a small trial with 84 mental health service users suggested improved intention to follow recommendations when written in plain language [6] . Trial data also exists on specific aspects related to health information, like comparing alternative ways of presenting numerical or statistical information and formats of information sharing [4, [8] [9] [10] . However, trustworthy and comprehensive PLRs may need to include the clinical or public health background related to the topic, conflicts of interest, available research evidence, judgments that are made, the rationale for a recommendation, the actual recommendation, and implementation considerations. As addressed in Evidence to Decision (EtD) frameworks, these facets are deemed essential to inform decision-making and are used widely by various organizations [11] [12] [13] [14] . A trial is necessary to empirically show that PLRs convey the intended messages from guidelines to broader populations and not only to the selected user groups that usually participate in ours and others' research. Understanding and interpreting recommendations correctly are the essential prerequisites for the general public to become effective selfmanagers of their health and to ultimately optimize their health outcomes [15] . Creating health information for the public that is accessible, reliable, and understandable is critical to scale science and evidence-based guidelines, which is especially important during the COVID-19 pandemic. We plan to undertake this trial, given the paucity of empirical evidence to guide our team and guideline developers as to how to best present PLRs and EtD facets to the public, which are critical to support their informed decision-making. This protocol describes the trial and details of the three leading trial sites. The objective of this study is to compare end-users' (youth, parents, and adult populations) understanding, accessibility and usability, satisfaction, intention to implement, and preference for COVID-19 recommendations when presented as plain language recommendations (PLRs) versus standard language versions (SLVs). We hypothesize that there will be a difference in understanding of information between the two formats. We also aim to understand the reasons for their choices through qualitative research. We will follow a mixed-methods approach: a randomized controlled trial (RCT) with qualitative interviews among a subset of participants. The trial is a pragmatic allocationconcealed, blinded superiority RCT with at least 240 participants in each population (parents, adult, and youth). The trial was preceded by preparatory engagement work with Canadian youth advisors, a Canadian parent advisory group, and an international adult Cochrane Consumer group, herein referred to as stakeholder groups. The youth site's preparatory engagement work was co-developed and implemented by two youth partners (MP and JR) in collaboration with LS, to ensure meaningful engagement efforts were embedded into the research process. We gathered input from stakeholders on COVID-19 priority topics and PLR content and format. Input from stakeholders helped us refine the PLR format to be evaluated with each population in the trial. We will conduct qualitative interviews with a subset of the participants who completed the trial to help contextualize and understand the results of the trial. Any amendments to this protocol will be made available via medRxiv. This protocol has been prepared in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) reporting guideline (Appendix 1) [16] . There are three online survey links, one for each respective population. Each link contains eligibility questions, the consent form, and study information for youth, parents, or adults. Participants will access the online survey corresponding to their respective population to enter the trial and provide implied consent by participating in the survey. Using the concealed allocation code of the intervention platform, SurveyMonkey (surveymonkey.com), participants will select their geographic region. Participants from each geographic region will be randomized to one of two recommendation topics, and then they will be randomized to a PLR format (intervention) or a SLV format (control) of the recommendation (Figure 1 ). The SLV is the original PDF guideline developed and published by an organization, such as the World Health Organization, from where the PLR information was extracted. Participants will complete an online survey consisting of Likert-scale questions, multiple-choice questions, open-ended questions, and demographic information. The survey is anonymous. . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted May 10, 2022. ; https://doi.org/10.1101/2022.05.09.22274842 doi: medRxiv preprint Following completion of the online survey, we will invite participants to take part in an optional qualitative interview that will allow them to reflect on their preference for the PLR or SLV format and help us understand the results of the quantitative survey. Confidentiality will be maintained by storing names and emails on a password protected device and secure network to which only authorized study personnel have access to. If participants decide to provide their name and email address to participate in the interview, receive the study results, or enter the draw (for a chance to win one out of five $50 CAD gift cards for the adult and parents' sites, one out of ten $25 CAD gift cards for the youth site) this personal information will not be linked to their survey answers. This is not a clinical trial, thus there are no foreseeable harms or health risks from participating. However, there is a possibility that participants may experience distress once they better understand the uncertainty in the underlying evidence, even if the recommendation itself is judged trustworthy. We provide the email address and contact information of the principal investigator and research coordinator. Participants can contact us to report any discomfort or seek further information. Each of the three sites will recruit participants from one of the three population groups: adults, parents or youth. SickKids Research Institute will recruit youth, Western University will recruit adults, and The University of Alberta will recruit parents. Global recruitment efforts will take place via social media. Coordination and oversight of the trial rests with the research team at . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted May 10, 2022. ; https://doi.org/10.1101/2022.05.09.22274842 doi: medRxiv preprint McMaster University (RC and HJS). Our study is also open for other sites who are interested in participating as active recruiters for one or more population. In this study, adults are defined as individuals self-reported to be 21 years of age or older, youth are defined as individuals self-reported to be between the ages of 15 to 24 years [17], and parents are defined as individuals self-reported to be 18 years or above and are a parent or legal guardian of a child under 18 years old. Participants can be from any country. For all sites, participants will need to be able to read and understand English. We expect variation in the English language proficiency and health literacy level among participants. Therefore, when collecting demographic information, questions related to language proficiency and familiarity with COVID-19 health information will be included to understand the participant's level of health literacy. We may adjust for these variables in our analysis if needed, although we expect them to be reasonably balanced between the SLV and PLR groups due to randomization. Each site will lead recruitment for the different population groups separately yet with similar and overlapping strategies. We will recruit English-speaking (mother tongue or fluent) participants globally through our experienced RecMap investigator team (https://covid19.recmap.org/about), the Cochrane Consumer Network and various Cochrane networks, guideline co-authors who interact with youth (including the international Young Persons' Advisory Groups), parents, and adult citizens. We plan to run public recruitment campaigns through identified youth, adult, and parent organizations' social media platforms (e.g., organizations' accounts on Twitter, Instagram, and Facebook) and newsletters. Each site will be responsible for monitoring their own recruitment, though all investigators will support overall recruitment for the trial (e.g., if recruitment falls behind for one recruitment site, other sites will help support recruitment for that group). Surveys will be administered through SurveyMonkey, where participants are screened for eligibility prior to allocation. Previous studies suggest that the target recruitment rates for such a trial are achievable in less than three months, and we will recruit at least 240 participants per group [18] [19] [20] . The average survey completion time is estimated to be 15-25 minutes, based on stakeholder feedback and pilot testing. As suggested by our stakeholders in the preparation of this trial, we will be inviting participants who complete the survey to enter a draw for a chance to win one of five $50 CAD gift cards for the adult and parents' sites. The youth site will invite youth to enter a draw for one of ten gift cards valued at $25 CAD. This is offered as a gesture and appreciation for completing the survey. In this trial, the intervention is the PLR, and the comparison is the SLV. Figure 2 below shows an example of the SLV format of a recommendation that will be used with the adult and youth participants and Figure 3 shows an example of a PLR format that will be presented to adult participants. . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted May 10, 2022. ; https://doi.org/10.1101/2022.05.09.22274842 doi: medRxiv preprint Through our pre-trial engagement work, we gathered input from youth (via online workshops) and from adult stakeholders (via online meetings) on high priority COVID-19 topics and on PLR content and format. Input from youth and adult stakeholders allowed us to choose two recommendations for the trial and refine the PLR format. For the parents' population, the PLRs were refined from collected feedback during online stakeholder meetings with parent groups. All PLRs for the trial were developed from the same template and refined using stakeholder feedback. The youth and parent PLRs' design and formatting are the same, as these groups gave similar feedback, while the adult PLRs are slightly different. In the trial, we will ask participants to read one format of a recommendation (PLR or SLV) to which they have been randomly allocated and then answer the online survey that takes an average of 15-25 minutes to complete. . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted May 10, 2022. We define understanding as the comprehension of key guideline content (e.g., year of publication, intent of recommendation, direction of recommendation, etc.). This outcome will be measured using seven multiple-choice questions about key concepts in the recommendation with four to six response options for each question and only one correct answer (total minimum score of 0, maximum score of 7). Based on previous work, a difference of 10% in understanding will be the minimally important difference between groups (an average difference of 1 correct answer) [18, 20, [22] [23] [24] . We define accessibility and usability as the ability to find/access and use the presented information. This outcome considers the three following domains: (1) how easy it was to find information, (2) how easy it was to understand the information (perception), and (3) whether the information was presented in a way that could be helpful for making an informed health decision. Participants will be asked to indicate the degree of agreement with six statements, measured using the 7-point Likert scale (1 being strongly disagree, 4 being neutral, and 7 being strongly agree). We will also include 1 open-ended question to get additional input on accessibility and usability. The outcome 'overall accessibility/usability of information' will be measured using the average of the 7-point Likert-type scale questions. We define satisfaction as participants' impression of the recommendation's presentation. We will ask participants about their level of satisfaction with different features of the format (e.g., order of information, length of document, etc.) [25] . Participants will be asked to indicate the degree of satisfaction with three questions measured using the original 7-point Likert-type scale (1 being very dissatisfied, 4 being neutral, and 7 being very satisfied). We will also include two open-ended questions to get their input on what they liked and disliked in the format. We define intended behavior as participants' intention in adopting and following the shared recommendation. We will ask participants if they have already followed the recommendation and have them respond with yes, no, unsure, prefer not to answer, or not applicable. Subsequently, we will ask how likely it is that they will follow the recommendation (if they haven't already) and share the recommendation with others, through two questions measured using a 7-point Likert-type scale (1 being very unlikely, 4 being neutral, and 7 being very likely). We define preference as a greater liking of one format over the other (PLR or SLV). After participants complete the tasks in the group they are randomized to, they will be asked to . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted May 10, 2022. ; https://doi.org/10.1101/2022.05.09.22274842 doi: medRxiv preprint compare the PLR and the SLV formats. Participants will review the alternative format and indicate their preference for one of the two formats using a 7-point Likert-type scale (1 being strongly preferring the SLV, 4 being same preference for both, and 7 being strongly preferring PLR). Participants will also have the chance to explain their choice in a text box. We will stratify our participants by region: Africa, Americas, Eastern Mediterranean, Europe, South-East Asia, and Western Pacific. We have not set a target sample per strata. The rationale behind stratification is to ensure an equal chance for participants from the same region to be randomized to either the intervention or control (as opposed to having all participants from Europe, for example, being randomized to the PLR format). After stratification, participants will be randomly assigned in a 1:1 ratio to recommendation topic 1 or 2, then will be randomized again in a 1:1 ratio to the PLR or the SLV arms (see Figure 1 ). Randomization will ensure that recommendation formats will be equally distributed across participants to get balanced judgments on outcomes. The allocation sequence is concealed using SurveyMonkey® software based on a commercial, but unknown algorithm without a pre-identified sequence. Participants will know that the trial is testing different formats to present health recommendations but will be blinded with respect to what formats are being compared and to the group to which they are allocated. Participants will not be aware of their random allocation to the PLR or SLV format until disclosure. Thus, participants will be blinded for all outcomes except the secondary outcome of preference. We will blind data analysts and investigators involved in data interpretation and manuscript writing to reduce bias in data analysis and interpretation [26, 27] . To reduce bias, we will draft each site's manuscript with general group labels (i.e., group A vs B) and agree on the final interpretation before the group allocation (optimized PLR or SLV) is revealed. The sample size was calculated using the primary outcome of understanding. For this twosided ( = 0.05) superiority analysis, these computations were made based on a t-test with the null hypothesis that there is no difference between the PLR version and the SLV in understanding of information. H0: PLR version = SLV H1: PLR version ≠ SLV We will determine whether we can reject the null hypothesis of no difference in understanding between the formats of presenting recommendations. We assume a correct response rate . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted May 10, 2022. ; https://doi.org/10.1101/2022.05.09.22274842 doi: medRxiv preprint (regarding understanding of information) of 75% in the PLR arm and 60% in the control arm [relative risk =1.25] based on a recent RCT and prior trials on Plain Language Summaries (PLS) of summary of findings table [20, 24] . With typical alpha (0.05) and beta (0.8) parameters and an allocation ratio of 1:1, 240 participants (120 in each arm) would be required (Stata/SE 16.0) [28] . Assuming 15% non-completion, we will recruit 282 participants from each population and adjust this number if non-completion is higher. Since we are using two different recommendation topics with each population, we might observe an interaction between the recommendation topic and our outcome of understanding. Thus, when we reach half of our intended sample size, we will conduct an interim analysis for a possible interaction effect. If the data suggests that there might be an interaction, we will consider modifying our initial sample size. This new sample size cannot be determined in advance since we cannot anticipate the magnitude of the potential interaction effect, but it will be determined based on published guidance on power calculations for credible subgroup effects [29] . If needed, we will submit an amendment that explains the new sample size and need for additional recruitment based on the magnitude of the interaction effect identified. In summary, an enhanced sample size, if indicated and feasible, will allow us to conduct more meaningful analysis by exploring the results by topic of recommendation. We will use the same survey template for all populations; however, the "understanding" questions will be appropriately different for each recommendation. We pilot tested the surveys during the pre-trial engagement work to gather feedback from Canadian youth advisors, Cochrane Consumer Network, adult stakeholders, and parent stakeholders. We had 10 youth, 29 adults, and 9 parents pilot test the survey and provide feedback on the time to complete the survey, length of the survey, clarity of questions, internet difficulties, and any other comments to enhance the survey experience. Revisions were made to the surveys using pilot test feedback until no errors or inconsistencies were detected and the surveys were easily understood. The survey language used for each population is tailored based on the feedback from stakeholders. Pilot test participant results will not be included in the final analysis. Each site's results will be analyzed separately, and we will explore subgroup effects within each population. These subgroup effects are the topic of recommendation, health literacy level, and English proficiency level of participants. We will also pool the results across sites and conduct a meta-analysis for our primary outcome of "understanding" and other secondary outcomes. In the final analysis, after pooling the results, we will explore for potential interaction related to the recommendation topic and participants' health literacy level. We will conduct the analyses using IBM SPSS® (Statistical Package for Social Sciences) version 23. We will summarize participant baseline characteristics and outcomes using means and standard deviations (SD) for continuous variables, and proportions for categorical variables. . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted May 10, 2022. ; https://doi.org/10.1101/2022.05.09.22274842 doi: medRxiv preprint We will perform a primary analysis including all randomized participants. We will exclude participants who take less than 10 minutes to complete the survey. For the outcome of understanding, we will use 2 tests and risk difference with 95% CIs to compare the proportion of correct responses between groups. For the outcomes of accessibility and satisfaction, we will use t-tests and mean differences 95% confidence intervals (95% CIs) to compare means and SDs between the intervention and control groups. Finally, we will present preference as mean (SD) overall and for both trial arms. Skewness, Shapiro-Wilk tests, and histograms will be used to evaluate whether the distribution was shifted toward the same preference in both groups. Levene's test of equal variances will be used for all t-tests and degrees of freedom will be adjusted for p < 0.05. We will report all p-values to three decimal places, with values less than 0.001 reported as < 0.001. We will consider statistical significance at p < 0.05. Furthermore, we will conduct a meta-analysis across the three trials by combining results of the three trials. Our a priori hypothesis is that there is no difference across the three populations despite the differences in population characteristics and slight difference in the presentation formats for each population. However, we will explore differences between trials applying the GRADE approach to evaluating inconsistency which includes the chi square test, the I 2 value, overlap in confidence intervals and the differences in the point estimates of effect for all outcomes [30] . At the end of each survey, participants will be invited to participate in a one-on-one semistructured interview, conducted by the research coordinator for each recruitment group. If interested, participants will voluntarily provide their email address, and the research coordinator will follow-up with them through email. These interviews will help us contextualize our results from the trial. From the list of participants who have agreed to participate in the qualitative interviews, we will randomize the email addresses to ensure maximum variation sampling. Data collection and analysis will be iterative, and data saturation will inform when data collection is complete. We will compensate interview participants for their time with a gift card valued at $25 CAD. Participants will be contacted via email to set up the interview and will also be provided with the consent form for participating in the semi-structured interviews. Following that, a Zoom invite will be shared with the participant. Prior to the start of the interview, the research coordinator conducting the interview will obtain verbal consent from the participant for participating in the interview and for the interview to be audio-recorded. Consent will be documented on a log by the coordinator. If participants decline recording of the interviews, we will not move forward with the interview. We will transcribe interview recordings verbatim, clean, and de-identify all interview transcripts. . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted May 10, 2022. ; https://doi.org/10.1101/2022.05.09.22274842 doi: medRxiv preprint All interviews will be conducted in English and will take approximately 30-60 minutes. Interviews will consist of a series of 8 open-ended questions that cover understanding, usability, usefulness, desirability, and preference regarding the PLR/SLV formats. We will pilot test the interview guide with the three populations to adjust questions and language for each population. All recordings will be stored on a password protected device and secure network and accessed only by members of the research team. The recordings will be kept for five years, at which point they will be destroyed. All transcribed recordings will be checked by the interviewer or a second research team member prior to coding and then de-identified. All interviews will be analyzed using thematic analysis, where transcripts or written notes will be coded using NVivo software (QSR, 2018) for data management. We will apply principles of framework analysis to assist in analyzing the qualitative data from interviews and open-ended survey comments [31] . Interpretation of results will be iterative as data coding proceeds. We will read the transcript, identify codes, group codes into categories and themes, seek outliers to develop depth in the themes, and assign them to emerging patterns and concepts. We will identify and report on themes and sub-themes, where applicable. We will repeat key responses back to participants during interviews as iterative member checking and we will continue interviews until we reach saturation on key themes. Further, we will develop joint displays, explicitly merging the results from the three sites' data sets through a side-by-side comparison to assess the coherence of the two types of data [32] . We will report our findings according to the Good Reporting of a Mixed Methods Study (GRAMMS) and Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines [33, 34] . For the quantitative results, we will pool the results across the three populations and conduct a meta-analysis for our primary outcome of "understanding" and other secondary outcomes. For the qualitative results, we will focus on a segment of attributes from the Honeycomb analytical framework to verify user's experiences with the different recommendation formats. These attributes are useful, usable, findable, and accessible [35] . We will explore results for each population separately and compare results across recruitment sites. Finally, we will crossmatch and compare the results of the qualitative interviews with those of the quantitative surveys and try to better understand and contextualize the RCT findings. Guideline developers typically create recommendations for health professionals or health agencies [1] . However, particularly in the context of COVID-19 and any future pandemics or topics of high public interest, the general public must have access to health recommendations that they can understand and trust [36] . For example, public understanding and acceptance is . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted May 10, 2022. ; https://doi.org/10.1101/2022.05.09.22274842 doi: medRxiv preprint required for implementation and uptake of many public health recommendations such as vaccination, using facial masks, and social distancing. Further, parents are making decisions for children who cannot make decisions for themselves, and they need trustworthy recommendations specific to this unique population (e.g., vaccine safety and efficacy for children). On the other hand, youth access health recommendations about COVID-19 and make independent decisions about implementing public health measures, like social distancing and face mask use [3] . It has become crucial to engage end-users in shaping behaviors and activities that will eventually affect them and their communities. Their involvement will improve the relevance, usefulness, and transparency of guidelines [37] . More importantly, it will ensure that these guideline products are understandable and acceptable. We believe that when the public is presented with plain language recommendations, they will have a better understanding of guideline recommendations. This trial is designed with the input of end-users from three populations: youth, adults, and parents. Results will inform the best ways to make recommendations understandable and accessible to the public, thus increasing the public's confidence in science and evidence uptake. After review, the Hamilton Integrated Research Ethics Board (HiREB) approved this study. The University of Alberta will also be submitting for ethics approval for their site. The results of this study will be published in peer-reviewed journals: one for each population, and one presenting the pooled results. We also aim to present the results in national and international conferences and distribute them through other media. The authors of this protocol follow the ICJME authorship criteria. Anonymous survey data will be publicly available from an open access online repository to be chosen within 2 years of data collection. This work is supported by the "Canadian Institutes of Health Research" (CIHR), grant number: GA3-177732. McMaster University is the sponsor of the trial and can be contacted through the principal investigator, Dr. Holger Schünemann at schuneh@mcmaster.ca. CIHR had no role in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. (which was not certified by peer review) The copyright holder for this preprint this version posted May 10, 2022. The study survey includes the consent form that describes the study purpose, confidentiality, potential risks, and voluntary participation (Appendix 2). Consent will be obtained from all participants in the study by overt action (i.e., by completing the survey). As for the interview, consent form will be shared via email (Appendix 3), and the research coordinator conducting the interview will obtain verbal consent from the participant for participating in the interview and for the interview to be audio-recorded. Anonymized survey data will be stored in SurveyMonkey® password-protected software. Participants will be given the option to provide their names and email addresses in a separate survey link. Names and email addresses will be stored in a separate document on a secure password-protected computer and will not be linked to the survey responses. Only designated members of the research team will have access to this data. HJS, KP, LH, NJB, and MO, are the principal investigators of the study and together with JM, EA, TK, DPR, SE, SDS and TL designed and established this research project. RC, LS, MM, SS, MP, and JR conducted pre-trial engagement work, piloted the survey and provided methodological input. RC, LS, MM and SS were responsible for drafting the ethics applications. RC and HJS were responsible for registering the protocol on the website, www.ClinicalTrials.gov. RC, LS, MM and SS are responsible for the coordination of the study. All authors participated in the writing and revision of the manuscript and approved its final version. The trial was registered on Clinicaltrials.gov, ID: NCT05358990. . CC-BY-NC-ND 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. 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