A multimethods randomized trial found that plain language versions improved adults understanding of health recommendations.

OBJECTIVES: To make informed decisions, the general population should have access to accessible and understandable health recommendations. To compare understanding, accessibility, usability, satisfaction, intention to implement, and preference of adults provided with a digital "Plain Language Recommendation" (PLR) format vs. the original "Standard Language Version" (SLV). STUDY DESIGN AND SETTING: An allocation-concealed, blinded, controlled superiority trial and a qualitative study to understand participant preferences. An international on-line survey. 488 adults with some English proficiency. 67.8% of participants identified as female, 62.3% were from the Americas, 70.1% identified as white, 32.2% had a bachelor's degree as their highest completed education, and 42% said they were very comfortable reading health information. In collaboration with patient partners, advisors, and the Cochrane Consumer Network, we developed a plain language format of guideline recommendations (PLRs) to compare their effectiveness vs. the original standard language versions (SLVs) as published in the source guideline. We selected two recommendations about COVID-19 vaccine, similar in their content, to compare our versions, one from the World Health Organization (WHO) and one from Centers for Disease Control and Prevention (CDC). The primary outcome was understanding, measured as the proportion of correct responses to seven comprehension questions. Secondary outcomes were accessibility, usability, satisfaction, preference, and intended behavior, measured on a 1-7 scale. RESULTS: Participants randomized to the PLR group had a higher proportion of correct responses to the understanding questions for the WHO recommendation (mean difference [MD] of 19.8%, 95% confidence interval [CI] 14.7-24.9%; P < 0.001) but this difference was smaller and not statistically significant for the CDC recommendation (MD of 3.9%, 95% CI -0.7% to 8.3%; P = 0.096). However, regardless of the recommendation, participants found the PLRs more accessible, (MD of 1.2 on the seven-point scale, 95% CI 0.9-1.4%; P < 0.001) and more satisfying (MD of 1.2, 95% CI 0.9-1.4%; P < 0.001). They were also more likely to follow the recommendation if they had not already followed it (MD of 1.2, 95% CI 0.7-1.8%; P < 0.001) and share it with other people they know (MD of 1.9, 95% CI 0.5-1.2%; P < 0.001). There was no significant difference in the preference between the two formats (MD of -0.3, 95% CI -0.5% to 0.03%; P = 0.078). The qualitative interviews supported and contextualized these findings. CONCLUSION: Health information provided in a PLR format improved understanding, accessibility, usability, and satisfaction and thereby has the potential to shape public decision-making behavior.

Plain Language vs Standard Format for Youth Understanding of COVID-19 Recommendations: A Randomized Clinical Trial.

Importance: To ensure that youths can make informed decisions about their health, it is important that health recommendations be presented for understanding by youths. Objective: To compare understanding, accessibility, usability, satisfaction, intention to implement, and preference of youths provided with a digital plain language recommendation (PLR) format vs the original standard language version (SLV) of a health recommendation. Design, Setting, and Participants: This pragmatic, allocation-concealed, blinded, superiority randomized clinical trial included individuals from any country who were 15 to 24 years of age, had internet access, and could read and understand English. The trial was conducted from May 27 to July 6, 2022, and included a qualitative component. Interventions: An online platform was used to randomize youths in a 1:1 ratio to an optimized digital PLR or SLV format of 1 of 2 health recommendations related to the COVID-19 vaccine; youth-friendly PLRs were developed in collaboration with youth partners and advisors. Main Outcomes and Measures: The primary outcome was understanding, measured as the proportion of correct responses to 7 comprehension questions. Secondary outcomes were accessibility, usability, satisfaction, preference, and intended behavior. After completion of the survey, participants indicated their interest in completing a 1-on-1 semistructured interview to reflect on their preferred digital format (PLR or SLV) and their outcome assessment survey response. Results: Of the 268 participants included in the final analysis, 137 were in the PLR group (48.4% female) and 131 were in the SLV group (53.4% female). Most participants (233 [86.9%]) were from North and South America. No significant difference was found in understanding scores between the PLR and SLV groups (mean difference, 5.2%; 95% CI, -1.2% to 11.6%; P = .11). Participants found the PLR to be more accessible and usable (mean difference, 0.34; 95% CI, 0.05-0.63) and satisfying (mean difference, 0.39; 95% CI, 0.06-0.73) and had a stronger preference toward the PLR (mean difference, 4.8; 95% CI, 4.5-5.1 [4.0 indicated a neutral response]) compared with the SLV. No significant difference was found in intended behavior (mean difference, 0.22 (95% CI, -0.20 to 0.74). Interviewees (n = 14) agreed that the PLR was easier to understand and generated constructive feedback to further improve the digital PLR. Conclusions and Relevance: In this randomized clinical trial, compared with the SLV, the PLR did not produce statistically significant findings in terms of understanding scores. Youths ranked it higher in terms of accessibility, usability, and satisfaction, suggesting that the PLR may be preferred for communicating health recommendations to youths. The interviews provided suggestions for further improving PLR formats. Trial Registration: ClinicalTrials.gov Identifier: NCT05358990.

Web-Based Knowledge Translation Tool About Pediatric Acute Gastroenteritis for Parents: Pilot Randomized Controlled Trial.

BACKGROUND: Acute gastroenteritis (AGE) in children is a leading cause of emergency department (ED) visits, resulting in substantial health care costs and stress for families and caregivers. The majority of pediatric AGE cases are caused by viral infections and can be managed at home using strategies to prevent dehydration. To increase knowledge of, and support health decision-making for, pediatric AGE, we developed a knowledge translation (KT) tool (fully automated web-based whiteboard animation video). OBJECTIVE: The aim of this study was to assess the potential effectiveness of the web-based KT tool in terms of knowledge, health care decision-making, use of resources, and perceived benefit and value. METHODS: A convenience sample of parents was recruited between December 18, 2020, and August 10, 2021. Parents were recruited in the ED of a pediatric tertiary care hospital and followed for up to 14 days after the ED visit. The eligibility criteria included parent or legal guardian of a child aged <16 years presenting to the ED with an acute episode of diarrhea or vomiting, ability to communicate in English, and agreeable to follow-up via email. Parents were randomized to receive the web-based KT tool (intervention) about AGE or a sham video (control) during their ED visit. The primary outcome was knowledge assessed before the intervention (baseline), immediately after the intervention, and at follow-up 4 to 14 days after ED discharge. Other outcomes included decision regret, health care use, and KT tool usability and satisfaction. The intervention group participants were invited to participate in a semistructured interview to gather additional feedback about the KT tool. RESULTS: A total of 103 parents (intervention: n=51, 49.5%, and control: n=52, 50.5%) completed the baseline and postintervention assessments. Of these 103 parents, 78 (75.7%; intervention: n=36, 46%, and control: n=42, 54%) completed the follow-up questionnaire. Knowledge scores after the intervention (mean 8.5, SD 2.6 vs mean 6.3, SD 1.7; P<.001) and at follow-up (mean 9.1, SD 2.7 vs mean 6.8, SD 1.6; P<.001) were significantly higher in the intervention group. After the intervention, parents in the intervention group reported greater confidence in knowledge than those in the control group. No significant difference in decision regret was found at any time point. Parents rated the KT tool higher than the sham video across 5 items assessing usability and satisfaction. CONCLUSIONS: The web-based KT tool improved parental knowledge about AGE and confidence in their knowledge, which are important precursors to behavior change. Further research is needed into understanding what information and delivery format as well as other factors influence parents' decision-making regarding their child's health. TRIAL REGISTRATION: ClinicalTrials.gov NCT03234777; https://clinicaltrials.gov/ct2/show/NCT03234777. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s40814-018-0318-0.

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.

INTRODUCTION: The COVID-19 pandemic underlined that guidelines and recommendations must be made more accessible and more understandable to the general public to improve health outcomes. The objective of this study is to evaluate, quantify, and compare the public's 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 (RecMap). METHODS AND ANALYSIS: This is a protocol for a multi-method study. Through an online survey, we will conduct pragmatic allocation-concealed, blinded superiority randomized controlled trials (RCTs) in three populations to test alternative formats of presenting health recommendations: adults, parents, and youth, with at least 240 participants in each population. Prior to initiating the RCT, our interventions will have been refined with relevant stakeholder input. The intervention arm will receive a plain language recommendation (PLR) format while the control arm will receive the corresponding original recommendation format as originally published by the guideline organizations (standard language version). Our primary outcome is understanding, and our secondary outcomes are accessibility and usability, satisfaction, intended behavior, and preference for the recommendation formats. Each population's results will be analyzed separately. However, we are planning a meta-analysis of the results across populations. At the end of each survey, participants will be invited to participate in an optional one-on-one, virtual semi-structured interview to explore their user experience. All interviews will be transcribed and analyzed using the principles of thematic analysis and a hybrid inductive and deductive approach. ETHICS AND DISSEMINATION: Through Clinical Trials Ontario, the Hamilton Integrated Research Ethics Board has reviewed and approved this protocol (Project ID: 3856). The University of Alberta has approved the parent portion of the trial (Project ID:00114894). Findings from this study will be disseminated through open-access publications in peer-reviewed journals and using social media. TRIAL REGISTRATION: Clinicaltrials.gov NCT05358990 . Registered on May 3, 2022.

Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial.

BACKGROUND: The role of remdesivir in the treatment of patients in hospital with COVID-19 remains ill defined in a global context. The World Health Organization Solidarity randomized controlled trial (RCT) evaluated remdesivir in patients across many countries, with Canada enrolling patients using an expanded data collection format in the Canadian Treatments for COVID-19 (CATCO) trial. We report on the Canadian findings, with additional demographics, characteristics and clinical outcomes, to explore the potential for differential effects across different health care systems. METHODS: We performed an open-label, pragmatic RCT in Canadian hospitals, in conjunction with the Solidarity trial. We randomized patients to 10 days of remdesivir (200 mg intravenously [IV] on day 0, followed by 100 mg IV daily), plus standard care, or standard care alone. The primary outcome was in-hospital mortality. Secondary outcomes included changes in clinical severity, oxygen- and ventilator-free days (at 28 d), incidence of new oxygen or mechanical ventilation use, duration of hospital stay, and adverse event rates. We performed a priori subgroup analyses according to duration of symptoms before enrolment, age, sex and severity of symptoms on presentation. RESULTS: Across 52 Canadian hospitals, we randomized 1282 patients between Aug. 14, 2020, and Apr. 1, 2021, to remdesivir (n = 634) or standard of care (n = 648). Of these, 15 withdrew consent or were still in hospital, for a total sample of 1267 patients. Among patients assigned to receive remdesivir, in-hospital mortality was 18.7%, compared with 22.6% in the standard-of-care arm (relative risk [RR] 0.83 (95% confidence interval [CI] 0.67 to 1.03), and 60-day mortality was 24.8% and 28.2%, respectively (95% CI 0.72 to 1.07). For patients not mechanically ventilated at baseline, the need for mechanical ventilation was 8.0% in those assigned remdesivir, and 15.0% in those receiving standard of care (RR 0.53, 95% CI 0.38 to 0.75). Mean oxygen-free and ventilator-free days at day 28 were 15.9 (± standard deviation [SD] 10.5) and 21.4 (± SD 11.3) in those receiving remdesivir and 14.2 (± SD 11) and 19.5 (± SD 12.3) in those receiving standard of care (p = 0.006 and 0.007, respectively). There was no difference in safety events of new dialysis, change in creatinine, or new hepatic dysfunction between the 2 groups. INTERPRETATION: Remdesivir, when compared with standard of care, has a modest but significant effect on outcomes important to patients and health systems, such as the need for mechanical ventilation. Trial registration: ClinicalTrials.gov, no. NCT04330690.

Transitions in Amyotrophic Lateral Sclerosis: Patient and Caregiver Experiences.

BACKGROUND: Amyotrophic lateral sclerosis (ALS) presents many transitions for persons/people with ALS (PwALS) and their caregivers. Transitions are passages from one life phase, condition, or status to another. We used qualitative methods to understand how PwALS and caregivers experience transitions throughout their ALS journey. METHODS: PwALS and their caregivers were recruited from a multidisciplinary ALS clinic in Edmonton, Canada. We recruited patients at the stage of ALS that home mechanical ventilation, a feeding tube, and/or assistive communication technology had been offered. Semi-structured interviews were audio-recorded, transcribed, and analyzed using qualitative thematic analysis. RESULTS: We interviewed 14 PwALS and 15 caregivers and identified 5 recurring themes. The importance of community was identified by many PwALS and caregivers who expressed feelings of loneliness and isolation. Most caregivers were spouses and couples navigated a change in their relationship roles as one spouse transitioned to becoming a caregiver while the other transitioned to dependency. The caregiver spouses reported a sense of "total responsibility" that encompassed continual vigilance for the PwALS's well-being, managing their household and finances. PwALS and caregivers reported transitioning to reliance on life-sustaining medical devices; early adoption and information on these devices increased their quality of life. Participants also wanted more and earlier information on advanced care planning. PwALS and caregivers identified adapting to new forms of communication as a necessity. CONCLUSION: ALS presents many transitions for PwALS and caregivers. Understanding these transitions is important for ALS healthcare professionals who seek to implement best care practices.

Does Exercise Timing Affect 24-Hour Glucose Concentrations in Adults With Type 2 Diabetes? A Follow Up to the Exercise-Physical Activity and Diabetes Glucose Monitoring Study.

OBJECTIVES: It is well known that exercise can improve the glycemic profile in individuals with type 2 diabetes (T2D). However, the optimal timing of exercise is often debated. Our aim in this study was to compare the effects of exercise performed at different times of the day and different timing in relation to meals on 24-hour glucose profiles in people with T2D. METHODS: Fourteen individuals with T2D were recruited and wore continuous glucose monitors for 12 days. During the 12 days, participants completed 4 conditions according to a randomized, crossover design: i) morning (fasting) exercise (MorEx), ii) afternoon exercise (AftEx), iii) evening exercise (EveEx) and iv) seated control. Exercise consisted of 50 minutes of walking at 5.0 km/h. RESULTS: Eight men and 6 women (age, 65±9.0 years; T2D duration, 10.5±6.8 years; mean glycated hemoglobin, 6.7±0.6%) were included in the analysis. Mean 24-hour continuously monitored glucose was 7.4±0.7 mmol/L, 7.3±0.7 mmol/L, 7.5±0.8 mmol/L and 7.5±0.7 mmol/L in the MorEx, AftEx, EveEx and control conditions, respectively, with no significant differences among the 4 conditions (p=0.55). MorEx had a lower respiratory exchange ratio compared with AftEx and EveEx (p<0.01). The decrease in glucose during exercise was less pronounced for MorEx compared with AftEx (p<0.05). CONCLUSIONS: Fifty minutes of walking at 3 different times of day and at different timing in relation to meals did not lower 24-hour glucose concentrations in people with T2D. The reasons why exercise was not effective at lowering glucose remain unclear.

Acute and Chronic Effects of Exercise on Continuous Glucose Monitoring Outcomes in Type 2 Diabetes: A Meta-Analysis.

Objective: To examine the acute and chronic effects of structured exercise on glucose outcomes assessed by continuous glucose monitors in adults with type 2 diabetes. Methods: PubMed, Medline, EMBASE were searched up to January 2020 to identify studies prescribing structured exercise interventions with continuous glucose monitoring outcomes in adults with type 2 diabetes. Randomized controlled trials, crossover trials, and studies with pre- and post-designs were eligible. Short-term studies were defined as having exercise interventions lasting ≤2 weeks. Longer-term studies were defined as >2 weeks. Results: A total of 28 studies were included. Of these, 23 studies were short-term exercise interventions. For all short-term studies, the same participants completed a control condition as well as at least one exercise condition. Compared to the control condition, exercise decreased the primary outcome of mean 24-h glucose concentrations in short-term studies (-0.5 mmol/L, [-0.7, -0.3]; p < 0.001). In longer-term studies, mean 24-h glucose was not significantly reduced compared to control (-0.9 mmol/L [-2.2, 0.3], p = 0.14) but was reduced compared to pre-exercise values (-0.5 mmol/L, [-0.7 to -0.2] p < 0.001). The amount of time spent in hyperglycemia and indices of glycemic variability, but not fasting glucose, also improved following short-term exercise. Among the shorter-term studies, subgroup, and regression analyses suggested that the timing of exercise and sex of participants explained some of the heterogeneity among trials. Conclusion: Both acute and chronic exercise can improve 24-h glucose profiles in adults with type 2 diabetes. The timing of exercise and sex of participants are among the factors that may explain part of the heterogeneity in acute glycemic improvements following exercise.