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

Transcription

1 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, Innovations, Opportunities, and Networks (ACTTION) Notes to Readers This implementation guide 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 Short-Form McGill Pain Questionnaire-2 ( ) Draft Short-Form McGill Pain Questionnaire-2 ( )

2 1 Introduction This document describes the CDISC implementation of the Short-Form McGill Pain Questionniare-2 (SFMP2) questionnaire, a standard questionnaire administered on a CRF that is typically used in clinical trials to measure pain response. The SHORT FORM CRF 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 table, which can be found at the CDISC website at: ( These specific implementation details for this specific questionnaire are meant to be used in conjunction with the SDTMIG, but are recorded separately since this questionnaire may be used in many different therapeutic area implementations. 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 questionnaire as part of CDISC Data Standards. This means that CDISC developed QSTESTCD and QSTEST for each question based on the actual question text on the questionnaire. 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 forms annotated with the CDISC SDTMIG submission values. CDISC has developed this documentation at no cost to copyright holder or any additional cost to users of the instrument beyond the normal licenses fees charged by the copyright holder. CDISC acknowledges Dr. R. Melzack and IMMPACT for the agreement to include the Short- Form in the CDISC data standards. Copyright information for this form is: Copyright R. Melzack and the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), All Rights Reserved Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 2

3 The author s consent ensures that the data captured using this instrument will be done so in a standardized manner thereby facilitating collection, database storage, reporting and regulatory review of that data. CDISC wants to emphasize that the existing copyright status as well as the existing procedures for licensing fees and using the instrument will remain exactly as they have been. Please follow the instrument owners own mechanisms for permissions and licenses if you have a need to use this questionnaire. 3 The QS Domain Model 3.1 Assumptions for Questionnaire Domain Model All assumptions for the QS domain from the SDTMIG apply for this supplemental implementation guide including those referenced in the CDISC notes. Additionally, the following assumptions apply to the Short-form McGill Pain Questionnaire-2: Short-Form McGill Pain Questionnaire-2 (SFMP2): is a standard clinical scale that is used to measure the major symptoms of both neuropathic and non-neuropathic pain that can be used in studies of epidemiology, natural history, pathophysiologic mechanisms, and treatment response. 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, but until a new method is identified, this will be the agreed approach. The evaluator of the questionnaire is stored in QSEVAL and for the form the SUBJECT provides the evaluation. Terminology a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology. b. Additional standardization of the QSORRES, QSSTRESC and QSSTRESN fields can be found in Section 4: Mapping Strategy. 3.2 Example for Short-form McGill Pain Questionnaire-2 Domain Model The SFMP2 example below shows the terminology for QSCAT, QSTEST, QSTESTCD and QSORRES that should be utilized for this scale. Values for QSORRES are for prospective data collection. Sponsors mapping legacy data should retain legacy values for QSORRES. A full list of value sets for QSORRES, QSSTRESC and QSSTRESN fields is provided in Section 4: Mapping Strategy Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3

4 Example: Short-form McGill Pain Questionnaire-2 (SFMP2) This example shows data from one subject collected at one visit for a SF- questionnaire. The example uses standard controlled terminology for QSTESTCD, QSTEST, QSCAT and QSSORRES for the SFMP2 measure. STUDYID=STUDYX and DOMAIN=QS are not shown in the example due to the foot print of the table Rows 1-22: Represent the 22 questions from the SFMP2. All original results are represented with the standard terminology in QSORRES. This result is then transformed into a Standard Numeric score in QSSTRESN. QS.XPT Row USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC QSSTRESN QSEVAL VISITNUM 1 1 SFMP201 SFMP2-Throbbing Pain SUBJECT SFMP202 SFMP2-Shooting Pain SUBJECT SFMP203 SFMP2-Stabbing Pain SUBJECT SFMP204 SFMP2-Sharp Pain SUBJECT SFMP205 SFMP2-Cramping Pain SUBJECT SFMP206 SFMP2-Gnawing Pain SUBJECT SFMP207 SFMP2-Hot-burning Pain SUBJECT SFMP208 SFMP2-Aching Pain SUBJECT SFMP209 SFMP2-Heavy Pain SUBJECT SFMP210 SFMP2-Tender SUBJECT SFMP211 SFMP2-Splitting Pain SUBJECT 1 12 SFMP2-Tiring- 12 SFMP212 Exhausting SUBJECT SFMP213 SFMP2-Sickening SUBJECT SFMP214 SFMP2-Fearful SUBJECT SFMP215 SFMP2-Punishing-Cruel SUBJECT 1 16 SFMP2-Electric-Shock 16 SFMP216 Pain SUBJECT 1 17 SFMP2-Cold-Freezing 17 SFMP217 Pain SUBJECT Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4

5 Row USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC QSSTRESN QSEVAL VISITNUM SFMP218 SFMP2-Piercing SUBJECT 1 19 SFMP2-Pain Caused by 19 SFMP219 Light Touch SUBJECT SFMP220 SFMP2-Itching SUBJECT 1 21 SFMP2-Tingling or Pins 21 SFMP221 and Needles SUBJECT SFMP222 SFMP2-Numbness SUBJECT 1 The data range text and numeric values for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below. SUPPQS.XPT STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL STUDY01 QS QSSEQ 1 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 1 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 1 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 1 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 2 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 2 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 2 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 2 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 3 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 3 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 3 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 3 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 4 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 4 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 4 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 4 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 5 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 5 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 5 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 5 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 6 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 6 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 6 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 6 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 7 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 7 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 7 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 7 RNGVALHI Range Value HI 10 CRF 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5

6 STUDY01 QS QSSEQ 8 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 8 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 8 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 8 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 9 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 9 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 9 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 9 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 10 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 10 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 10 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 10 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 11 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 11 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 11 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 11 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 12 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 12 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 12 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 12 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 13 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 13 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 13 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 13 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 14 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 14 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 14 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 14 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 15 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 15 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 15 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 15 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 16 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 16 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 16 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 16 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 17 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 17 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 17 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 17 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 18 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 18 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 18 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 18 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 19 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 19 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 19 RNGVALLO Range Value Lo 0 CRF 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 6

7 STUDY01 QS QSSEQ 19 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 20 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 20 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 20 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 20 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 21 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 21 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 21 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 21 RNGVALHI Range Value HI 10 CRF STUDY01 QS QSSEQ 22 RNGTXTLO Range Text Lo none CRF STUDY01 QS QSSEQ 22 RNGTXTHI Range Text Hi worst possible CRF STUDY01 QS QSSEQ 22 RNGVALLO Range Value Lo 0 CRF STUDY01 QS QSSEQ 22 RNGVALHI Range Value HI 10 CRF 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 7

8 4 SDTM Mapping Strategy 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, QSORRESU, QSSTRESC, QSSTRESN, and QSSTRESU) should be populated for each questionnaire. If a result variable is not included in the table for a questionnaire, it should not be populated. QSTESTCD= SFMP201 SFMP222 QSTEST= SFMP2-Throbbing Pain SFMP2- Numbness QSORRES QSSTRESC QSSTRESN Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 8

9 SUPPLEMENTAL QUALIFIERS NAME CODES The following table contains an additional standard name codes for use in the Supplemental Qualifiers for Questionnaires (SUPPQS) special-purpose datasets. 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 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 9