Epworth Sleepiness Scale (ESS)

Transcription

1 Epworth Sleepiness Scale (ESS) Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials Prepared by CDISC Questionnaires Sub-team Notes to Readers This supplement is intended to be used with other CDISC User Guides for specific Therapeutic/Disease Areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical trials. Revision History Date Version Summary of Changes Epworth Sleepiness Scale (ESS) 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 1

2 1 Introduction This document describes the CDISC implementation of the Epworth Sleepiness Scale (ESS), a standard questionnaire that is typically used in clinical trials to provide an assessment of a subject s general level of daytime sleepiness. The ESS questionnaire preceded the CDISC CDASH CRF standards and based on its copyright status cannot be modified to CDASH standards. The representation of data collected for this questionnaire is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) QS domain model, which can be found on the CDISC website at: ( These specific implementation details for this questionnaire are meant to be used in conjunction with the SDTMIG. All questionnaire documentation can be found on the CDISC web site at: ( The CDISC Intellectual Property Policy can be found on the CDISC web site at: ( 1.1 Representations and Warranties, Limitations of Liability, and Disclaimers This document is a supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material. 2 Copyright Status CDISC has obtained permission to include the ESS questionnaire as part of CDISC Data Standards. This means that CDISC developed QSTESTCD and QSTEST values for each question based on the questionnaire source reference. The instrument itself was not changed. The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) case report form annotated with the CDISC SDTMIG submission values. Note: CDISC controlled terminology is maintained by NCI EVS. The most recent version should be accessed through the CDISC website at: ( CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond any normal licensing fees charged by the copyright holder. CDISC acknowledges Dr. Murray W. Johns for the agreement to include the Epworth Sleepiness Scale (ESS) in the CDISC data standards Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 2

3 3 The QS Domain Model 3.1 Assumptions for Questionnaire Domain Model All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the Epworth Sleepiness Scale are listed below. Epworth Sleepiness Scale (ESS): ESS is an 8-item, self-administered questionnaire. Subjects rate the 8 items on a scale of The questionnaire evaluator should be stored in QSEVAL. For ESS, the evaluator is defined as STUDY SUBJECT since the instrument is self-administered. 2. The ESS is evaluated by the subject based on usual way of life in recent times. The evaluation interval of RECENT TIMES is placed in variable QSEVINTX, which is a variable added in SDTM v 1.4/SDTMIG v3.1.4 for evaluation intervals that are not able to be represented in ISO 8601 format. Sponsors using this supplement prior to the release of SDTM v1.4/sdtmig v3.1.4 should submit QSEVINTX as a supplemental variable. 3. Terminology: a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology. b. A full list of value sets for test and result fields is provided in Section 4: SDTM Mapping Strategy Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3

4 3.2 Example for Epworth Sleepiness Scale (ESS) QS Domain Model The ESS example below shows the terminology used to implement the questionnaire in the QS domain. This example shows the data for one subject collected at one visit. The example uses CDISC controlled terminology for QSTESTCD, QSTEST, and QSCAT. Rows 1-8: Represent the 8 questions from the ESS questionnaire. All original results are represented with preferred terminology in QSORRES. The corresponding numeric result from the scale is placed in QSSTRESN and in character format in QSSTRESC. QS.XPT Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES 1 STUDYX QS P ESS0101 ESS01-Sitting and Reading ESS slight chance of dozing 2 STUDYX QS P ESS0102 ESS01-Watching TV ESS moderate chance of dozing 3 STUDYX QS P ESS0103 ESS01-Sitting Inactive in a Public Place ESS would never doze 4 STUDYX QS P ESS0104 ESS01-Passenger for Hour Without Break ESS slight chance of dozing 5 STUDYX QS P ESS0105 ESS01-Lying Down to Rest In Afternoon ESS slight chance of dozing 6 STUDYX QS P ESS0106 ESS01-Sitting and Talking to Someone ESS high chance of dozing 7 STUDYX QS P ESS0107 ESS01-Sitting Quietly After Lunch ESS would never doze 8 STUDYX QS P ESS0108 ESS01-In Car Stopped Few Minutes Traffic ESS moderate chance of dozing Row QSSTRESC QSSTRESN QSSTAT QSBLFL QSEVAL VISITNUM QSDTC QSEVINTX 1 (cont) 1 1 Y STUDY SUBJECT RECENT TIMES 2 (cont) 2 2 Y STUDY SUBJECT RECENT TIMES 3 (cont) 0 0 Y STUDY SUBJECT RECENT TIMES 4 (cont) 1 1 Y STUDY SUBJECT RECENT TIMES 5 (cont) 1 1 Y STUDY SUBJECT RECENT TIMES 6 (cont) 3 3 Y STUDY SUBJECT RECENT TIMES 7 (cont) 0 0 Y STUDY SUBJECT RECENT TIMES 8 (cont) 2 2 Y STUDY SUBJECT RECENT TIMES 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4

5 4 SDTM Mapping Strategy ESS specific mapping strategy: This section is used for reference with the annotated CRF for further details on the CRF data capture and to understand the alignment of the questionnaire to the SDTM QS domain. It provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated for the questionnaire. QSTESTCD=ESS0101 QSTEST= ESS01- Sitting and Reading QSTESTCD=ESS0102 QSTEST= ESS01-Watching TV QSTESTCD=ESS0103 QSTEST= ESS01-Sitting Inactive in a Public Place QSTESTCD=ESS0104 QSTEST= ESS01-Passenger for Hour Without Break QSTESTCD=ESS0105 QSTEST= ESS01-Lying Down to Rest In Afternoon QSTESTCD=ESS0106 QSTEST= ESS01-Sitting and Talking to Someone QSTESTCD=ESS0107 QSTEST= ESS01-Sitting Quietly After Lunch QSTESTCD=ESS0108 QSTEST= ESS01-In Car Stopped Few Minutes Traffic QSORRES QSSTRESC QSSTRESN would never doze 0 0 slight chance of dozing 1 1 moderate chance of dozing 2 2 high chance of dozing 3 3 End of Document 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5