Neuropathic Pain Scale (NPS)

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Neuropathic Pain Scale (NPS) Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials Prepared by Business & Decision Life Sciences and the CDISC

1 Neuropathic Pain Scale (NPS) Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials Prepared by Business & Decision Life Sciences and the CDISC Questionnaire 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 Neuropathic Pain Scale (NPS) Draft Neuropathic Pain Scale (NPS) 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved

2 1 Introduction This document describes the CDISC implementation of the Neuropathic Pain Scale (NPS) questionnaire, a standard questionnaire that is typically used in clinical trials to assess distinct pain qualities associated with neuropathic pain. The NPS questionnaire preceded the CDISC CDASH CRF standards and based on its public domain 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 at 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 This instrument is copyright approved. CDISC has included the Neuropathic Pain Scale (NPS) as part of CDISC Data Standards. Hence, CDISC developed QSTESTCD and QSTEST for each question based on the actual question text on the questionnaire. There may be many versions of this questionnaire in the public domain or copyright questionnaire. CDISC has chosen to use this version as the data standard. The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) case report forms 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. ( CDISC has developed this documentation at no cost to users of the instrument. CDISC acknowledges Brad Galer and Mark Jensen: Development and preliminary validation of a pain measure specific to neuropathic pain: The Neuropathic Pain Scale. NEUROLOGY 1997; 48: ) for including the NPS in the CDISC data standards Clinical Data Interchange Standards Consortium, Inc. All rights reserved

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 Neuropathic Pain Scale are listed below. Neuropathic Pain Scale (NPS): NPS is a self-report questionnaire consisting of 10 items. Subjects rate 9 items on a numeric rating scale of 0-10, and describe the pain for one item. 1. Visual analog or numeric rating scales used within a questionnaire with a range of text and numeric values are indicated in the SUPPQS domain with: QNAM=RNGTXTLO QNAM=RNGVALLO QNAM=RNGTXTHI QNAM=RNGVALHI By storing this information in SUPPQS, it is available for interpretation purposes. The SDS QS Team is researching alternative methods to handle this data in the future, but until a new method is identified, this will be the recommended approach. a. The low and high anchor text is stored in QSORRES with the numeric values of these anchors stored in QSSRTESC and QSSTRESN. All other numeric values are stored in QSORRES, QSSTRESC and QSSTRESN. 2. The questionnaire evaluator is stored in QSEVAL. For NPS, the evaluator is defined as the STUDY SUBJECT. 3. Terminology: a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology. b. A full list of value sets for qualifier and result fields is provided in Section 4: SDTM Mapping Strategy Clinical Data Interchange Standards Consortium, Inc. All rights reserved

4 3.2 Example for Neuropathic Pain Scale (NPS) QS Domain Model The NPS 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 for an NPS questionnaire. The example uses CDISC controlled terminology for QSTESTCD, QSTEST, and QSCAT. QSBLFL is NULL based on VISITNUM = 2. All original results for the NUMERICAL RATING SCALE 11-POINT are populated with the low and high anchor text and the scoring of 1 to 9 in QSORRES. This numerical result (scoring of 0 to 10) is then populated in QSSTRESC and QSSTRESN. Rows 1-7: Row 8: Rows 9 and 10: Rows 11-13: Row 21: Row 22: Row 33: Row 34: Represents the questions 1-7 from the NPS form. Represents the question 8 from the NPS form. Only one result is supposed to be checked for this question. Any unchecked result is not represented in SDTM. In this example first result of question 8 is checked. As first result of question 8 is checked, QSTESTCD = NPS0108A and NPS0108B are filled with text. Represents the questions 9 and 10 from the NPS form In this example second result of question 8 is checked. As second result of question 8 is checked, QSTESTCD = NPS0108C is filled with text. In this example third result of question 8 is checked. As third result of question 8 is checked, QSTESTCD = NPS0108D is filled with text. qs.xpt Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT 1 STUDYX QS P NPS 0101 NPS01-Tell Us How Intense Your Pain Is NPS STUDYX QS P NPS 0102 NPS01-Tell Us How Sharp Your Pain Feels NPS Not sharp STUDYX QS P NPS 0103 NPS01-Tell Us How Hot Your Pain Feels NPS STUDYX QS P NPS 0104 NPS01-Tell Us How Dull Your Pain Feels NPS The most dull sensation imaginable STUDYX QS P NPS 0105 NPS01-Tell Us How Cold Your Pain Feels NPS STUDYX QS P NPS 0106 NPS01-Sensitiv Skin to Light Touch/Cloth NPS STUDYX QS P NPS 0107 NPS01-Tell Us How Itchy Your Pain Feels NPS STUDYX QS P NPS0108 NPS01-Describe Time Quality of Your Pain NPS I feel background pin all the time I feel background pin all the time 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4

5 and occasional flare-ups (break through pain) some of the time. and occasional flare-ups (break through pain) some of the time. 9 STUDYX QS P NPS 0108A NPS01-Describe the Background Pain NPS Intense pain Intense pain 10 STUDYX QS P NPS 0108B NPS01-Describe the Flare-up Pain NPS Rather ok Rather ok 11 STUDYX QS P NPS 0109 NPS01-Tell How Unpleasant Your Pain Feel NPS STUDYX QS P NPS 0110A NPS01-How Intense is Your Deep Pain NPS 13 STUDYX QS P NPS 0110B NPS01-How Intense is Your Surface Pain NPS STUDYX QS P NPS 0101 NPS01-Tell Us How Intense Your Pain Is NPS No pain STUDYX QS P NPS 0102 NPS01-Tell Us How Sharp Your Pain Feels NPS P0002 The most hot sensation imaginable 16 STUDYX QS 3 NPS 0103 NPS01-Tell Us How Hot Your Pain Feels NPS ( on fire ) 17 STUDYX QS P NPS 0104 NPS01-Tell Us How Dull Your Pain Feels NPS 18 STUDYX QS P NPS 0105 NPS01-Tell Us How Cold Your Pain Feels NPS STUDYX QS P NPS 0106 NPS01-Sensitiv Skin to Light Touch/Cloth NPS STUDYX QS P NPS 0107 NPS01-Tell Us How Itchy Your Pain Feels NPS P0002 I feel a single type of pain all the I feel a single type of pain all the 21 STUDYX QS 8 NPS0108 NPS01-Describe Time Quality of Your Pain NPS time. time. 22 STUDYX QS P NPS 0108C NPS01-Describe Single Type Pain All Time NPS Limited pain Limited pain 23 STUDYX QS P NPS 0109 NPS01-Tell How Unpleasant Your Pain Feel NPS STUDYX QS P NPS 0110A NPS01-How Intense is Your Deep Pain NPS 25 STUDYX QS P NPS 0110B NPS01-How Intense is Your Surface Pain NPS STUDYX QS P NPS 0101 NPS01-Tell Us How Intense Your Pain Is NPS STUDYX QS P NPS 0102 NPS01-Tell Us How Sharp Your Pain Feels NPS STUDYX QS P NPS 0103 NPS01-Tell Us How Hot Your Pain Feels NPS STUDYX QS P NPS 0104 NPS01-Tell Us How Dull Your Pain Feels NPS 30 STUDYX QS P NPS 0105 NPS01-Tell Us How Cold Your Pain Feels NPS Not cold STUDYX QS P NPS 0106 NPS01-Sensitiv Skin to Light Touch/Cloth NPS STUDYX QS P NPS 0107 NPS01-Tell Us How Itchy Your Pain Feels NPS P0003 I feel a single type of pain I feel a single type of pain 33 STUDYX QS 8 NPS0108 NPS01-Describe Time Quality of Your Pain NPS sometimes. Other times, I am pain free. sometimes. Other times, I am pain free. 34 STUDYX QS P NPS 0108D NPS01-Describe the Occasional Pain NPS Moderate pain Moderate pain 35 STUDYX QS P NPS 0109 NPS01-Tell How Unpleasant Your Pain Feel NPS P0003 The most intense deep pain 36 STUDYX QS 11 NPS 0110A NPS01-How Intense is Your Deep Pain NPS sensation imaginable 37 STUDYX QS P NPS 0110B NPS01-How Intense is Your Surface Pain NPS Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5

6 Row QSMETHOD QSBLFL QSEVAL VISITNUM QSDTC QSDY 1 (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) STUDY SUBJECT (cont) STUDY SUBJECT (cont) STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) STUDY SUBJECT (cont) STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) STUDY SUBJECT (cont) STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT (cont) NUMERICAL RATING SCALE 11-POINT STUDY SUBJECT Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 6

7 The ranges (both numeric and text) of the numeric 10-point scale need to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below. This is the current approach for this type of data until a better metadata solution is determined. QEVAL is not populated, since this is objective data based on the NPS CRF. (Only subject P0001 is represented in this example) suppqs.xpt STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL STUDYX QS P0001 QSTESTCD NPS 0101 RNGTXTLO Range Text Lo No pain ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0101 RNGTXTHI Range Text Hi The most intense pain sensation imaginable ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0101 RNGVALLO Range Value Lo 0 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0101 RNGVALHI Range Value Hi 10 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0102 RNGTXTLO Range Text Lo Not sharp ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0102 RNGTXTHI Range Text Hi The most sharp sensation imaginable ( like a knife ) ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0102 RNGVALLO Range Value Lo 0 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0102 RNGVALHI Range Value Hi 10 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0103 RNGTXTLO Range Text Lo Not hot ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0103 RNGTXTHI Range Text Hi The post hot sensation imaginable ( on fire ) ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0103 RNGVALLO Range Value Lo 0 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0103 RNGVALHI Range Value Hi 10 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0104 RNGTXTLO Range Text Lo Not dull ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0104 RNGTXTHI Range Text Hi The most dull sensation imaginable ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0104 RNGVALLO Range Value Lo 0 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0104 RNGVALHI Range Value Hi 10 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0105 RNGTXTLO Range Text Lo Not cold ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0105 RNGTXTHI Range Text Hi The most cold sensation imaginable ( Freezing ) ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0105 RNGVALLO Range Value Lo 0 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0105 RNGVALHI Range Value Hi 10 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0106 RNGTXTLO Range Text Lo Not sensitive ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0106 RNGTXTHI Range Text Hi The most sensitive sensation imaginable ( raw skin ) ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0106 RNGVALLO Range Value Lo 0 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0106 RNGVALHI Range Value Hi 10 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0107 RNGTXTLO Range Text Lo Not itchy ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0107 RNGTXTHI Range Text Hi The most itchy sensation imaginable ( like poison oak ) ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0107 RNGVALLO Range Value Lo 0 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0107 RNGVALHI Range Value Hi 10 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0109 RNGTXTLO Range Text Lo Not unpleasant ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0109 RNGTXTHI Range Text Hi The most unpleasant sensation imaginable ( intolerable )² ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0109 RNGVALLO Range Value Lo 0 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0109 RNGVALHI Range Value Hi 10 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0110A RNGTXTLO Range Text Lo No deep pain ASSIGNED 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 7

8 STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL STUDYX QS P0001 QSTESTCD NPS 0110A RNGTXTHI Range Text Hi The most intense deep pain sensation imaginable ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0110A RNGVALLO Range Value Lo 0 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0110A RNGVALHI Range Value Hi 10 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0110B RNGTXTLO Range Text Lo No surface pain ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0110B RNGTXTHI Range Text Hi The most intense surface pain sensation imaginable ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0110B RNGVALLO Range Value Lo 0 ASSIGNED STUDYX QS P0001 QSTESTCD NPS 0110B RNGVALHI Range Value Hi 10 ASSIGNED 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 8

9 4 SDTM Mapping Strategy NPS 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 also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated for the questionnaire. If a result variable is not included in the table for a questionnaire, it should not be populated. QSMETHOD NUMERICAL RATING SCALE 11-POINT Applicable to QSTESTCD NPS0101-NPS0107 and NPS0109-NPS0110B QSTESTCD = NPS0101, QSTEST= NPS01-Tell Us How Intense Your Pain Is No pain 0 0 The most intense pain sensation imaginable QSTESTCD = NPS0102, QSTEST= NPS01-Tell Us How Sharp Your Pain Feels Not sharp 0 0 The most sharp sensation imaginable ( like a knife ) QSTESTCD = NPS0103, QSTEST= NPS01-Tell Us How Hot Your Pain Feels Not hot 0 0 The most hot sensation imaginable ( on fire ) QSTESTCD = NPS0104, QSTEST= PS01-Tell Us How Dull Your Pain Feels Not dull 0 0 The most dull sensation imaginable Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 9

10 QSTESTCD = NPS0105, QSTEST= NPS01-Tell Us How Cold Your Pain Feels Not cold 0 0 The most cold sensation imaginable ( freezing ) QSTESTCD = NPS0106, QSTEST= NPS01-Sensitiv Skin to Light Touch/Cloth Not sensitive 0 0 The most sensitive sensation imaginable ( raw skin ) QSTESTCD = NPS0107, QSTEST= NPS01-Tell Us How Itchy Your Pain Feels Not itchy 0 0 The most itchy sensation imaginable ( like poison oak ) QSTESTCD = NPS0108, QSTEST= NPS01-Describe Time Quality of Your Pain QSORRES QSSTRESC I feel a background pain all of the time and occasional flare-ups (break-through pain) some of the time I feel a background pain all of the time and occasional flare-ups (break-through pain) some of the time I feel a single type of pain all the time I feel a single type of pain all the time I feel a single type of pain only sometimes. Other times, I am free I feel a single type of pain only sometimes. Other times, I am free QSTESTCD = NPS0109, QSTEST= NPS01-Tell How Unpleasant Your Pain Feel Not unpleasant 0 0 The most unpleasant sensation imaginable ( intolerable ) QSTESTCD = NPS0110A, QSTEST= NPS01-How Intense is Your Deep Pain No deep pain 0 0 The most intense deep pain sensation imaginable Clinical Data Interchange Standards Consortium, Inc. All rights reserved

11 QSTESTCD = NPS0110B, QSTEST= NPS01-How Intense is Your Surface Pain No surface pain 0 0 The most intense surface pain sensation imaginable SUPPQS.QVAL value standardization for data range text values QNAM QVAL Applicable to QSTESTCD RNGTXTLO No pain NPS0101 RNGTXTLO Not sharp NPS0102 RNGTXTLO Not hot NPS0103 RNGTXTLO Not dull NPS0104 RNGTXTLO Not cold NPS0105 RNGTXTLO Not sensitive NPS0106 RNGTXTLO Not itchy NPS0107 RNGTXTLO Not unpleasant NPS0109 RNGTXTLO No deep pain NPS0110A RNGTXTLO No surface pain NPS0110B RNGTXTHI The most intense pain sensation imaginable NPS0101 RNGTXTHI The most sharp sensation imaginable ( like a knife ) NPS0102 RNGTXTHI The most hot sensation imaginable ( on fire ) NPS0103 RNGTXTHI The most dull sensation imaginable NPS0104 RNGTXTHI The most cold sensation imaginable ( freezing ) NPS0105 RNGTXTHI The most sensitive sensation imaginable ( raw skin ) NPS0106 RNGTXTHI The most itchy sensation imaginable ( like poison oak ) NPS0107 RNGTXTHI The most unpleasant sensation imaginable ( intolerable ) NPS0109 RNGTXTHI The most intense deep pain sensation imaginable NPS0110A RNGTXTHI The most intense surface pain sensation imaginable NPS0110B 5 Supplemental Qualifier Name Codes The following table contains an additional standard name codes for use in the Supplemental Qualifiers for Questionnaires (SUPPQS) special-purpose dataset. QNAM QLABEL Applicable Domains RNGTXTLO Range Text Lo QS RNGTXTHI Range Text Hi QS RNGVALLO Range Value Lo QS RNGVALHI Range Value Hi QS End of Document 2014 Clinical Data Interchange Standards Consortium, Inc. All rights reserved

Short-Form McGill Pain Questionniare-2 (SHORT-FORM MPQ-2)

Short-Form McGill Pain Questionniare-2 ( ) Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials Prepared by CDISC and Analgesic Clinical Trial Translations,