Communicating Uncertainty - Protocol for Randomized Trial

Study Overview
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Brief Summary
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Randomized trial testing 6 forms of a communication summarizing the results of a recent study (about the effects of wearing glasses on reducing covid infection risk). The goal of the trial is to test the effect of different language options to describe uncertainty, and of including the margin of error around the main result.

Detailed Description
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The study is designed as a proof-of-concept exercise to develop and test a communication meant to summarize the results of a recent randomized trial examining the effects of wearing glasses on the chance of developing COVID-19. The objectives of the randomized trial are: To compare the effects of three ways of communicating the overall uncertainty of the effects of wearing glasses to reduce the chance of getting COVID and To compare the effects of including the margin of error (confidence interval) compared to not including it. We will conduct an online, parallel group, individually randomized, pragmatic trial using a 3x2 factorial design, ie, 3 uncertainly language options (GRADE language, colloquial language or none 2 options for the statistical margin of error for the main results (margin of error language or none).

Official Title
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Communicating Uncertainty About the Effects of Wearing Glasses to Reduce the Chance of Getting COVID (Corona Virus Disease): Protocol for a Randomized Trial

Conditions
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COVID-19

Intervention / Treatment
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* Other: Overall uncertainty language


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >= 18 years old literate in English or Norwegian currently residing in Norway or the United States Exclusion Criteria: individuals who regularly wear any kind of glasses (i.e., prescription or sunglasses) all or most of the time

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 3 options for describing bias/uncertainty about results 2 options for margin of error around main result (we will run the trial twice on 2 different online platforms)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GRADE + margin of error<br>Overall uncertainty using GRADE* language AND margin of error around main result * Based on the Cochrane Effective Practice and Organisation of Care Group's guidance for communicating the certainty of evidence based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assessing the certainty of evidence | Other: Overall uncertainty language<br>* We are testing different forms of information about overall study uncertainty and margin of error around main result<br>* Other names: Margin of error around main result;|
| Active Comparator: Colloquial language AND margin of error<br>Colloquial language developed to describe overall study uncertainty AND margin of error around main result | Other: Overall uncertainty language<br>* We are testing different forms of information about overall study uncertainty and margin of error around main result<br>* Other names: Margin of error around main result;|
| Active Comparator: No overall uncertainty language AND margin of error<br>No overall uncertainty language AND margin of error around main result | Other: Overall uncertainty language<br>* We are testing different forms of information about overall study uncertainty and margin of error around main result<br>* Other names: Margin of error around main result;|
| Active Comparator: GRADE -No margin of error<br>Overall uncertainty using GRADE* language and NO margin of error around main result * Based on the Cochrane Effective Practice and Organisation of Care Group's guidance for communicating the certainty of evidence based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assessing the certainty of evidence | Other: Overall uncertainty language<br>* We are testing different forms of information about overall study uncertainty and margin of error around main result<br>* Other names: Margin of error around main result;|
| Active Comparator: Colloquial - No margin of error<br>Colloquial language developed to describe overall study uncertainty and NO margin of error around main result | Other: Overall uncertainty language<br>* We are testing different forms of information about overall study uncertainty and margin of error around main result<br>* Other names: Margin of error around main result;|
| Placebo Comparator: No overall uncertainty language AND no margin of error<br>No overall uncertainty language and NO margin of error around main result | Other: Overall uncertainty language<br>* We are testing different forms of information about overall study uncertainty and margin of error around main result<br>* Other names: Margin of error around main result;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| understanding of overall uncertainty of benefit (of wearing glasses to reduce the chance of covid infection) | How sure about the effect (4 point scale from very unsure to very sure) | within 1 day | 
| understanding of overall uncertainty of harm (of wearing glasses to reduce the chance of covid infection) | How sure about the effect (4 point scale from very unsure to very sure) | within 1 day | 
| sufficiency of what is known about the effects of wearing glasses to reduce the chance of covid infection | How sure about the effect (4 point Likert scale) | within 1 day | 
| Understanding the margin of error around the benefit of wearing glasses to reduce covid | this is a co-primary outcome which will be used only to compare the 3 versions that include the margin of error to the 3 versions that do not | within 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| perceived effect of wearing glasses to reduce chance of covid infection | What is the effect on a 5 point scale (lowers a lot, lowers a little, no effect, increase a little, increases a lot | within 1 day | 
| how likely is it that wearing glasses reduces the chance of covid infection | 4 point scale (very likely, likely, unlikely, very unlikely) | within 1 day | 
| intended behavior (if there were a surge in covid in your area, how likely would you be to wear glasses to reduce the chance of covid infection | 4 point scale (very likely, likely, unlikely, very unlikely | within 1 day | 
| intended behavior (if there were very few cases of covid in your area, how likely would you be to wear glasses to reduce the chance of covid infection | 4 point scale (very likely, likely, unlikely, very unlikely | within 1 day | 
| perceptions fo information provided (trustworthy summary?) | 4 point Likert scale (strongly agree, agree, disagree, strongly disagree) | within 1 day | 
| perceptions fo information provided (sufficient summary?) | 4 point Likert scale (strongly agree, agree, disagree, strongly disagree) | within 1 day | 
| perceptions fo information provided (clarity of info about benefit) | 4 point scale (very clear, clear, unclear, very unclear) | within 1 day | 
| perceptions fo information provided (clarity of info about harm) | 4 point scale (very clear, clear, unclear, very unclear) | within 1 day | 
| perceptions fo information provided (info helpful?) | 4 point scale (very helpful, helpful, unhelpful, very unhelpful) | within 1 day | 
| perceptions fo information provided (share info with others?) | 4 point scale (definitely yes, probably yes, probably no, definitely no) | within 1 day | 
| Decisional conflict (hard to make decision) | 4 point LIkert scale (strongly agree, agree, disagree, strongly disagree) | within 1 day | 
| Decisional conflict (made informed decision) | 4 point LIkert scale (strongly agree, agree, disagree, strongly disagree) | within 1 day | 
| Decisional conflict (satisfied with decision) | 4 point LIkert scale (strongly agree, agree, disagree, strongly disagree) | within 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colloquial language, uncertainty, bias