Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD)

OVERVIEW

The U. S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) has determined that the Asthma Daytime Symptom Diary (ADSD) and the Asthma Nighttime Symptom Diary (ANSD) have demonstrated adequate evidence of content validity and cross-sectional measurement properties (i.e., internal consistency reliability, test-retest reliability, convergent validity, and known-groups validity) to measure symptoms of asthma. The qualification statement supports the ADSD and ANSD as measures of asthma symptoms in drug development. Further evaluation is needed on the instruments’ longitudinal measurement properties (e.g., ability to detect change) and the interpretation of clinically meaningful within-patient change in scores. Sponsors seeking to use the ADSD and/or the ANSD as a primary or secondary endpoint measure in confirmatory studies should discuss plans with the appropriate CDER review division. For additional details regarding FDA’s qualification statement, please visit FDA's Clinical Outcome Assessment Qualification Program site.

  • Measure name: Asthma Daytime Symptom Diary (ADSD)

  • Version: 1.0

  • Number of items: 6

  • Target patient population: Adults and adolescents (12 years of age and older) diagnosed with mild to severe asthma

  • Concept of interest: Self-reported severity of core, defining symptoms of asthma

  • Recall period: Since getting up this morning

    • Night: Every night before respondent goes to bed​

  • Response scale: 11-point (0-10) numeric rating scale (NRS)

  • Mode of data collection: Electronic administration is recommended for the ADSD and previous studies were conducted using a handheld electronic device.

  • Measure name: Asthma Nighttime Symptom Diary (ANSD)

  • Version: 1.0

  • Number of items: 6

  • Target patient population: Adults and adolescents (12 years of age and older) diagnosed with mild to severe asthma

  • Concept of interest: Self-reported severity of core, defining symptoms of asthma

  • Recall period: Since going to bed last night

    • Morning: Every morning when respondent gets up

  • Response scale: 11-point (0-10) numeric rating scale (NRS)

  • Mode of data collection: Electronic administration is recommended for the ANSD and previous studies were conducted using a handheld electronic device.
     

ADSD  ITEMS
 

ANSD  ITEMS

USER MANUAL

Available with license


LANGUAGE AVAILABILITY

Available translations of the ADSD and the ANSD can be obtained when licensing the measure(s). To assure standardized translations, users are not permitted to translate the ADSD or the ANSD without prior, written permission from the PRO Consortium. Please contact us for more details.

PREFERRED TRANSLATION VENDOR FOR ADSD and ANSD
RWS Life Sciences

LICENSING
Licensing fees are assessed on a per trial/per measure basis for commercial use.​

  • ​PRO Consortium Member Firms:

    • First Language​                                                                                           $1000 USD

    • Each Additional/Available Language                                                        $500 USD

  • Non-Member Organizations​

    • First Language​                                                                                          $4000 USD

    • Each Additional/Available Language                                                      $2000 USD

Non-commercial use is assessed on a case-by-case basis for appropriateness and applicability.

 

To license an available version of the ADSD and/or ANSD, please complete the licensing form. All of the information provided in the form will be kept strictly confidential. For questions about the measure, please contact us.

PUBLICATIONS

Gater A, Nelsen L, Fleming S, Lundy J.J, Bonner N, Hall R, Marshall C, Staunton H, Krishnan JA, Stoloff S, Schatz M, Haughney J on behalf of the Patient-Reported Outcome Consortium’s Asthma Working Group. Assessing asthma symptoms in adolescents and adults: qualitative research supporting development of the Asthma Daily Symptom Diary. Value in Health 2016;9:440-450