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Table 1 Items Included in the Original and Revised Versions of the CSD-AD© and SD NRS

From: Content validity of a sleep numerical rating scale and a sleep diary in adults and adolescents with moderate-to-severe atopic dermatitis

Instrument

Original Version (used in phase II)

Revised/Final Version

Change Made

CSD-AD©

Item 1: What time did you get into bed?

Morning item 1: What time did you get into bed?

No change

Item 2: What time did you try to go to sleep?

Morning item 2: What time did you try to go to sleep?

No change

Item 3: How long did it take you to fall asleep?

Morning item 3: How long did it take you to fall asleep?

No change

Item 4a: How many times did you wake up, not counting your final awakening?

Morning item 4: How many times did you wake up due to the symptoms of atopic dermatitis (for example itching, burning), not counting the final time you woke up for the day?

Added “due to the symptoms of atopic dermatitis (for example itching, burning)”

Replaced “final awakening” by “final time you woke up for the day”

Examples provided in the instructions adjusted accordingly

Item 5b: In total, how long did these itch-related awakenings last?

Morning item 5: In total, how long did the awakenings related to the symptoms of atopic dermatitis (for example itching, burning) last?

Added “awakenings related to the symptoms of atopic dermatitis (for example itching, burning)”

Item 4b: How many times did you wake up due to itching, not counting your final awakening?

Morning item 6: How many times did you wake up, for other things (for example to drink water, to go to the bathroom), not counting the final time you woke up for the day?

Added “for other things (for example to drink water, to go to the bathroom)”

Replaced “final by “final time you woke up for the day”

Item 5a: In total, how long did these awakenings last?

Morning item 7: In total, how long did these awakenings related to other things (for example to drink water, to go to the bathroom) last?

Added “for other things (for example to drink water, to go to the bathroom)”

Item 6: What time was your final awakening?

Morning item 8: What time did you wake up for the day?

Replaced “final awakening” by “time did you wake up for the day”

(No item)

New morning item 9: What time did you get out of bed for the day?

Insertion of item 7 from the Consensus Sleep Diary [11] to be able to derive sleep metrics

Item 7: How would you rate the quality of your sleep?

Morning item 10: How would you rate the quality of your sleep?

No change

Item 8: How rested or refreshed did you feel when you woke up for the day?

Morning item 11: How rested or refreshed did you feel when you woke up for the day?

No change

Item 9: Did you take any sleep medication last night?

(Deleted)

Removed because sleep medications are usually not allowed in clinical trials of atopic dermatitis

Item 10a: How many times did you nap or doze?

Item 10b: In total, how long did you nap or doze?

Evening item 1: How many times did you nap?

No change; broken down into separate questions

Evening item 2: In total, how long did you nap?

Evening item 3: How many times did you doze off?

Evening item 4: In total, how long did you doze off?

SD NRS

In instructions, atopic dermatitis abbreviated “AD”

In instructions, “atopic dermatitis” spelled out

Changed from “AD” to “atopic dermatitis”

Anchor for the maximum score (10) defined as “I cannot sleep at all”

Anchor for the maximum score (10) defined as “I did not sleep at all”

Changed from “cannot” to “did not”

  1. Abbreviations: CSD-AD© Consensus Sleep Diary, atopic dermatitis version, SD NRS sleep disturbance numerical rating scale