Example 3: What is the burden associated with filling out forms (participant and/or site staff)? by Megan Othus

Survey fatigue

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Stress level scale of 1-5

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Endpoint options: time to complete, satisfaction with survey

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The amount of time it takes. And the method used- electronic versus written

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75 items or less, 15-20 minutes duration

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Endpoint: number of minutes to complete all forms
Rule: median < 10 minutes

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Time to start the survey from time of notification

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Time to complete surveys.

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Endpoint: self-reported burden using scale

Develop and revise form until 80% of 10 person focus groups agree with moving it forward

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Endpoint: average time it takes to fill out survey, WIWI survey

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Endpoint: time spent filling out forms. Rule : WIWI , >15 minutes completing forms =burden

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Time!

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Time for participants vs. incentives vs. cognitive abilities

Burden of staff time to collect and confirm.

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Study coordinator time

Exhausting!

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Do you suggest being purposeful about switching the order that forms are presented to patients so it’s not always form X which is first etc?

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Endpoint: Time needed to complete form; Rule: 75% of participants complete the form in under 15 minutes.

Endpoint: proportion of patients that report excessive burden

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Rule: 60% report excessive burden then not feasible

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Literacy 📖

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Time it takes to fill out the survey and how difficult it is to answer the question

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Time to complete forms and number of uncompleted forms

EP: post form survey answer yes to if they would do again. Rule. More than 20% say no..failure

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Easy/Moderate/Difficult or a likert scale 1-10 (1= easy; 10= pain in the ***)

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Endpoint: score burden from 1-5 (5 bad) and ask participants after they fill out forms what their score is

Rule: avg score > 3 is considered high burden

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Likert scale assessing patients opinion on the difficulty of the instrument (1-5)

Size of font??? Contrast? Multiple languages?

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