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| Name | Class |
|---|---|
| Western University | OTHER |
| The Hospital for Sick Children | OTHER |
| University of Alberta | OTHER |
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Coronavirus Disease (COVID-19) recommendations are usually developed for healthcare professionals (for example Doctors, health organizations, etc.). It is important to make sure that these recommendations can be used and understood by everyone. This study aims to make COVID-19 recommendations more accessible and understandable for parents and caregivers, adults, and youth.
This is a two-arm superiority randomized controlled trial. The primary objective is to compare the understanding of key guideline information between the Plain Language Recommendation (PLR) (intervention) and the Standard Language Version (SLV- original recommendation as available in the published guideline) (comparison). Secondary outcomes include accessibility and usability of the information, satisfaction with the presentation, intended behavior to follow the information in the recommendation, and preference toward one of the two presentations. Recruitment will be global for the three populations (youth, parents, and adults), using three different online links. Data will be collected using a survey with 1:1 randomization to the intervention and subsequent demographic questions. Superiority will be declared if a minimal difference of 10% in understanding is achieved between the two groups (an average difference of 1 correct answer).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plain Language Recommendation (PLR) | Experimental | New easy to read COVID-19 recommendations available on the COVID19 Living Map of Recommendations and Gateway to Contextualization (RecMap). |
|
| Standard Language Version (SLV) | Active Comparator | Original recommendation as initially published by the guideline organization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plain Language Recommendation (PLR) | Other | New easy to read COVID-19 recommendations available on the COVID19 Living Map of Recommendations and Gateway to Contextualization (RecMap). |
| Measure | Description | Time Frame |
|---|---|---|
| Understanding with Multiple Choice Questions | The primary outcome is understanding. Understanding is defined as the correct comprehension of key guideline content (year of publication, intent of the recommendation, direction of recommendation, etc.). This outcome will be measured with 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). | Duration of survey (approximately 25 minutes) at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Accessibility and Usability on a Seven-Point Likert Scale | Accessibility and Usability is defined 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 have to indicate the degree of agreement with six statements, measured using the original 7-point Likert scale (1 being strongly disagree, 4 being neutral, and 7 being strongly agree). The outcome 'overall accessibility of information' will be measured using the 7-point Likert-type scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holger J Schunemann, MD, PHD | McMaster University | Study Chair |
| Kevin Pottie | Western University | Principal Investigator |
| Martin Offringa | The Hospital for Sick Children Research Institute | Principal Investigator |
| Nancy Butcher | The Hospital for Sick Children Research Institute | Principal Investigator |
| Lisa Hartling | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8S 4L8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37548983 | Derived | Stallwood L, Sammy A, Prebeg M, Relihan J, Baba A, Charide R, Sayfi S, Elliott SA, Hartling L, Munan M, Richards DP, Mathew JL, Kredo T, Mbuagbaw L, Motilall A, Scott SD, Klugar M, Lotfi T, Stevens AL, Pottie K, Schunemann HJ, Butcher NJ, Offringa M; RecMap Members. Plain Language vs Standard Format for Youth Understanding of COVID-19 Recommendations: A Randomized Clinical Trial. JAMA Pediatr. 2023 Sep 1;177(9):956-965. doi: 10.1001/jamapediatrics.2023.2686. | |
| 37421995 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Standard Language Version (SLV) | Other | Original recommendation as initially published by the guideline organization. |
|
| Duration of survey (approximately 25 minutes) at baseline |
| Satisfaction on a Seven-Point Likert Scale | Satisfaction is defined as participants' impression of the recommendation's presentation. This will be measured using questions related to participants' level of satisfaction with the different features of the format (e.g. feature of explaining the certainty of the evidence). Participants will have to indicate the degree of satisfaction with three questions measured using the original 7-point Likert-type scale (11 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neutral, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied). Participants will also have to answer three open-ended questions to get their input on what they liked and disliked in the format. | Duration of survey (approximately 25 minutes) at baseline |
| Intended Behavior on a Seven-Point Likert Scale and Multiple Choice Questions | Intended behavior is defined as participants' intention in adopting and following the shared recommendation. Participants will answer a question on whether they have already followed and implemented the recommendation in their jurisdiction and have them respond with yes, no, unsure, or not applicable. Subsequently, they will be asked how likely it is that they will follow and share the recommendation through two questions measured using a 7-point Likert-scale (1 = very unlikely, 2 = unlikely, 3 = somewhat unlikely, 4 = neutral, 5 = somewhat likely, 6 = likely, 7 = very likely. | Duration of survey (approximately 25 minutes) at baseline |
| Preference on a Seven-Point Likert-Scale | Preference is defined as a greater liking of one format over the other (PLR or SLV). All participants will get to compare the optimized PLR and the SLV; after having completed the tasks in the group they were randomized to, participants will review the alternative format and indicate their preference for one of the two formats using a 7-point Likert-type scale (1 = strongly prefer SLV, 2 = prefer SLV, 3 = somewhat prefer SLV, 4 = same preference for SLV and PLR, 5 = somewhat prefer PLR, 6 = prefer PLR, 7 = strongly prefer PLR). | Duration of survey (approximately 25 minutes) at baseline |
| Derived |
| Elliott SA, Scott SD, Charide R, Patterson-Stallwood L, Sayfi S, Motilall A, Baba A, Lotfi T, Suvada J, Klugar M, Kredo T, Mathew JL, Richards DP, Butcher NJ, Offringa M, Pottie K, Schunemann HJ, Hartling L. A multimethods randomized trial found that plain language versions improved parents' understanding of health recommendations. J Clin Epidemiol. 2023 Sep;161:8-19. doi: 10.1016/j.jclinepi.2023.06.018. Epub 2023 Jul 6. |
| 36641457 | Derived | Charide R, Stallwood L, Munan M, Sayfi S, Hartling L, Butcher NJ, Offringa M, Elliott S, Richards DP, Mathew JL, Akl EA, Kredo T, Mbuagbaw L, Motillal A, Baba A, Prebeg M, Relihan J, Scott SD, Suvada J, Falavigna M, Klugar M, Lotfi T, Stevens A, Pottie K, Schunemann HJ. 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 three randomized controlled trials and qualitative user-experience studies. Trials. 2023 Jan 14;24(1):27. doi: 10.1186/s13063-023-07067-9. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |