Pain Relief (PR) Notes to Readers

Transcription

1 Pain (PR) 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 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 1

2 Revision History Date Version Summary of Changes Pain (included in the NV domain for public review) Pain 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 2

3 1 Introduction This document describes the CDISC implementation of the Pain questionnaire, a standard public domain questionnaire administered on a CRF that is typically used in clinical trials to measure pain response. Please refer to the CDISC Pain Standards User Guide ( for information on developing this data standard by the sponsor, Analgesic Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) and their working group, STandardized ANalgesic DAtabase for Research, Discovery, and Submissions (STANDARDS). The Pain concept preceded the CDISC CDASH CRF standards and has no standard CRF, based on its public domain status. CDASH standard CRFs may be developed in the future. The representation of data collected for this questionnaire is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) QS domain table (SDTMIG), which can be found at the CDISC website at These 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 ( The CDISC Intellectual Property Policy can be found in the ABOUT CDISC/Bylaws & Policies section of the web site. 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 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 3

4 2 Copyright Status This instrument is in the public domain. CDISC has included the general Pain concepts as part of CDISC Data Standards. This means that CDISC developed QSCAT, QSTESTCD and QSTEST for the questions based on the actual question text on the questionnaire. There may be many versions of this questionnaire in the public domain. 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 are not available, due to the general Pain concepts not having a published standard CRF. 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. Reference: Handbook of Pain Assessment, Third Edition [Hardcover] Chapter 2 - Self-Report Scales and Procedures for Assessing Pain in Adults: Dennis C. Turk PhD (Editor), Ronald Melzack PhD (Editor) This definitive clinical reference comprehensively reviews the most advanced methods for assessing the person in pain. The field's leading authority s present essential information and tools for evaluating psychosocial, behavioral, situational, and medical factors in patients' subjective experience, functional impairment, and response to treatment. Empirically supported instruments and procedures are detailed, including self-report measures, observational techniques, psychophysiological measures, and more. Best-practice recommendations are provided for assessing the most prevalent pain syndromes and for working with children, older adults, and people with communication difficulties. The book also weighs in on the limitations of existing methods and identifies key directions for future research. CDISC acknowledges Dennis Turk and Ronald Melzack for inclusion of the Pain concepts as part of the CDISC SDTM Data standards Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4

5 3 The QS Domain Model 3.1 Assumptions for the Pain 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 Pain : 1. The questions relevant to measurement of Pain are in the public domain and routinely used in a variety of Pain/Analgesic condition studies. The Pain measures are a rating of the relief of pain at specified time points. 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=RNGTXTHI QNAM=RNGVALLO 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. Pain is usually measured in a verbal rating scale with a categorical list of text and numeric values that are indicated in the SUPPQS domain as described above. For a verbal scale, the subject selects a descriptive phrase. Since the design of Pain/Analgesic studies is continually evolving, often using different numeric values for the same text values across drug projects and studies, the STANDARDS Working Group realized that further terminology standardization in the Pain Therapeutic Area will be needed on an ongoing basis. Such additional future terminology standards, where applicable, may be addressed by ACTTION in subsequent versions. CDISC and the ACTTION working group have suggested draft terminology for these pain scales. At the current time, standardization of these terms for data pooling will need to be performed in analysis datasets using the CDISC Analysis Data Model (ADaM) and the Statistical Analysis Plan (SAP). 2. Pain assessments include a variety of types of measurements beyond relief in general. This is normally specified in the question being asked as Rate your pain relief. Individual Pain test codes and test names are defined for each of these Pain questions. Pain Average Pain Least Pain Worst Pain 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5

6 Minimum Pain Maximum Pain 3. The following Pain measures are also used in specific pain condition studies and are illustrated in the example below. This is normally specified in individual questions. Individual Pain test codes and test names are defined for each of these pain relief questions. Starting Pain at Least 1/2 Gone Time to Perceptible Pain Was there Perceptible Pain Time to Meaningful Pain Was there Meaningful Pain 4. The location of pain relief is populated in QSLOC with CDISC Location Terminology indicating the anatomical location when specified in a study. If multiple pain relief locations are specified separately at the same time point, separate records will be created for each anatomical location in order to enable analysis for each location. When a study is conducted for a specific type of overall pain (.ex Fibromyalgia, Diabetic Neuropathy, etc.), the Medical History MHTERM for the MHCAT=PRIMARY DIAGNOSIS will indicate the type and time reference of pain historically observed. Refer to the Pain Standards User Guide ( for a data example of this MH record. If this is not captured, the Trial Summary domain would contain an indication parameter to define the pain being investigated in the study. 1. Pain is relief at the time the question is asked. All the other test names above imply a period of time. For example, Least Pain in the last week could easily have a different value from Least Pain in the last year. This period of time should be clear in the data collection and, if it is, should be represented in the SDTM dataset as described below. The time period of evaluation of Pain is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as a duration as shown in examples a-c below. Specific points in time should use the QSDTC field as shown in example d. In cases where the evaluation interval cannot be precisely described as an ISO 8601 duration, the evaluation period should be represented using the Supplemental Qualifier EVLINTTX, as shown in examples e-g. In cases that are related to protocol-specified points in time, the QSTPT variable may be used as in example h. a. over last 24 hours QSEVLINT = -PT24H b. over last hour QSEVLINT = -PT1H c. over last week QSEVLINT = -P1W 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 6

7 d. right now QNAM=EVLINTTX QVAL= right now e. over the last night s sleep QNAM=EVLINTTX QVAL= Over last Night s Sleep f. Starting Pain is measured from the beginning of treatment QNAM=EVLINTTX QVAL= Pain from beginning of treatment g. since last medication: - QNAM=EVLINTTX QVAL= Since last medication h. At use of rescue medication this type of CRF is usually supplied at non-scheduled time point when rescue medication is administered to assist in relieving pain. The CDISC visit field is populated with VISIT= study design VISIT value QSTPT= Rescue Medication as a planned time point 5. Frequency/Timing of Pain measures captured in a study is normally included in the protocol s table of time and events (e.g., Hourly, Multiple times per day, periodic, etc.) For example, a rating of pain relief in the past 24 hours could be administered every day or once each week, and a rating of average pain relief in the past 7 days could be administered every week or once a month. The CDISC Trial Design model represents information about the protocol as parameters in the Trial Summary domain, and a terminology request is being submitted for the TSPARMCD=RATNGFRQ and TSPARM=Frequency of Rating Capture to address this need. CDISC will announce an alternative if one is determined to be necessary upon further investigation. 6. Activity during Pain measurements is populated in SUPPQS with QNAM=MOVETYP and QLABEL = values provided below. A. Not specified B. At rest C. With Movement 7. The evaluator of the questionnaire is stored in QSEVAL and for the Pain the Subject provides the evaluation of pain relief. 8. Terminology A. Requests for controlled terminology for the QSCAT, QSTESTCD, QSTEST and QSMETHOD variables are being submitted through the CDISC controlled terminology process. Controlled terminology is still under development for the Pain data standards, thus some values in the examples are not CDISC controlled terms. Verify demonstrated terminology against current standards before adopting it. B. Controlled terminology code lists are being submitted for the VERBAL RATING SCALE 6-POINT value lists as displayed in section 4. C. The specific mapping strategy for Pain using standard QS fields is described in Section 4: Mapping Strategy for the following required fields Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 7

8 Section 4 provides guidance on how the result and category variables in the QS domain need to be populated for a questionnaire. (ex. QSORRES, QSORRESU, QSSTRESC, QSSTRESN, QSSTRESU, QSCAT and QSMETHOD) If a result variable is not included in the table for a questionnaire, it should not be populated. D. SUPPQS is used for additional data standardization with those data items listed in the Appendix C: Supplemental Qualifiers. 3.2 Examples for Pain Domain Model Example 1: 5-Point Verbal Rating Scale This example shows data from one subject collected at three visits for a Back Pain 5-Point Rating Scale questionnaire evaluated over the past 24 hours. The example uses standard controlled terminology for QSTESTCD, QSTEST, QSCAT, QSMETHOD and QSLOC for the Pain scale. QSSTRESN will be set to the standard numeric value and then converted into QSSTRESC. SUPPQS is populated with the data range text and numeric values. Rows 1-3: qs.xpt Represent 3 visit values of Back Pain ratings for USUBJID= from a Pain 5-Point Rating Scale Form. All original results are represented in QSORRES, which is then transformed into a Standard Numeric rating QSSTRESN, which is then also copied to a standard character value in QSSTRESC. Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC QSSTRESN QSMETHOD 1 STUDYX QS PR01 - Pain A LITTLE VERBAL RATING SCALE 5-1 PR POINT 2 STUDYX QS PR01 - Pain VERBAL RATING SCALE 5-2 PR01001 SOME 2 2 POINT 3 STUDYX QS PR01 - Pain A LOT OF VERBAL RATING SCALE 5-3 PR POINT Row QSLOC QSEVAL VISITNUM QSDTC QSDY QSEVLINT 1 (cont d) BACK SUBJECT PT24H 2 (cont d) BACK SUBJECT PT24H 3 (cont d) BACK SUBJECT PT24H The data range text and numeric values for data collection values need to be populated in SUPPQS. These data range values for Pain are mapped to SUPPQS domain as follows. The standard terminology for QNAM and QLABEL are listed below. suppqs.xpt STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 8

9 STUDYX QS QSSEQ 1 RNGTXTLO Range Text Lo NO CRF STUDYX QS QSSEQ 1 RNGTXTHI Range Text Hi COMPLETE CRF STUDYX QS QSSEQ 1 RNGVALLO Range Value Lo 0 CRF STUDYX QS QSSEQ 1 RNGVALHI Range Value HI 4 CRF STUDYX QS QSSEQ 2 RNGTXTLO Range Text Lo NO CRF STUDYX QS QSSEQ 2 RNGTXTHI Range Text Hi COMPLETE CRF STUDYX QS QSSEQ 2 RNGVALLO Range Value Lo 0 CRF STUDYX QS QSSEQ 2 RNGVALHI Range Value HI 4 CRF STUDYX QS QSSEQ 3 RNGTXTLO Range Text Lo NO CRF STUDYX QS QSSEQ 3 RNGTXTHI Range Text Hi COMPLETE CRF STUDYX QS QSSEQ 3 RNGVALLO Range Value Lo 0 CRF STUDYX QS QSSEQ 3 RNGVALHI Range Value HI 4 CRF Example 2: 5-Point Verbal Rating Scale This example shows data from one subject collected at three visits for a Worst Back Pain 5-Point Verbal Rating Scale questionnaire evaluated over the past 24 hours. The example uses standard controlled terminology for QSTESTCD, QSTEST, QSCAT, QSMETHOD and QSLOC for the Pain scale. QSSTRESN will be set to the standard numeric value and then converted into QSSTRESC. Rows 1-3: Represent 3 visit values of Worst Back Pain for USUBJID= from a Pain 5-Point Verbal Rating Scale Form. All original results are represented in QSORRES, which is then transformed into a Standard Numeric rating QSSTRESN, which is then also copied to a standard character value in QSSTRESC. SUPPQS is populated with the data range text and numeric values. qs.xpt Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC QSSTRESN QSMETHOD 1 STUDYX QS PR01 - Worst Pain VERBAL RATING SCALE 5-1 PR01006 A LITTLE 1 1 POINT 2 STUDYX QS PR01 - Worst Pain VERBAL RATING SCALE 5-2 PR01006 SOME 2 2 POINT 3 STUDYX QS PR01 - Worst Pain COMPLETE VERBAL RATING SCALE 5-3 PR POINT Row QSLOC QSEVAL VISITNUM QSDTC QSDY QSEVLINT 1 (cont d) BACK SUBJECT PT0H 2 (cont d) BACK SUBJECT PT24H 3 (cont d) BACK SUBJECT PT24H The data range text and numeric values for data collection values need to be populated in SUPPQS. These data range values for Pain are mapped to SUPPQS domain as follows. The standard terminology for QNAM and QLABEL are listed below Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 9

10 suppqs.xpt STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL STUDYX QS QSSEQ 1 RNGTXTLO Range Text Lo NO CRF STUDYX QS QSSEQ 1 RNGTXTHI Range Text Hi COMPLETE CRF STUDYX QS QSSEQ 1 RNGVALLO Range Value Lo 0 CRF STUDYX QS QSSEQ 1 RNGVALHI Range Value HI 4 CRF STUDYX QS QSSEQ 2 RNGTXTLO Range Text Lo NO CRF STUDYX QS QSSEQ 2 RNGTXTHI Range Text Hi COMPLETE CRF STUDYX QS QSSEQ 2 RNGVALLO Range Value Lo 0 CRF STUDYX QS QSSEQ 2 RNGVALHI Range Value HI 4 CRF STUDYX QS QSSEQ 3 RNGTXTLO Range Text Lo NO CRF STUDYX QS QSSEQ 3 RNGTXTHI Range Text Hi COMPLETE CRF STUDYX QS QSSEQ 3 RNGVALLO Range Value Lo 0 CRF STUDYX QS QSSEQ 3 RNGVALHI Range Value HI 4 CRF Example 3: Pain Rating and General Pain Questions collected in a Surgical Condition Study This example is based on a legacy sponsor specific CRF, in which the Pain Intensity measure is taken prior to dosing and then at hour readings. The Pain results are also obtained at specific hour time points for Pain and Starting Pain ½ Gone. At the end of the Pain capture, the following questions were asked for Was there meaningful pain relief, Time to meaningful pain relief, Was there perceptible pain relief, and the Time to perceptible pain relief. This example shows data from one subject collected with data collected at hour time points indicated with QSTPT=Pre-Treatment, 1H, 2H, 4H, & 6H collecting the following fields: 1. Pain 5-Point Verbal Rating Scale 2. Starting Pain at Least ½ Gone 3. Time to Perceptible Pain 4. Was there Perceptible Pain 5. Time to Meaningful Pain 6. Was there Meaningful Pain 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 10

11 The example uses standard controlled terminology for QSTESTCD, QSTEST, QSCAT, QSMETHOD and QSLOC for the Pain scale. QSSTRESN will be set to the standard numeric value and then converted into QSSTRESC for the Verbal Rating Scale 5-Point. SUPPQS is populated with the data range text and numeric values. Rows 1-12: qs.xpt Represent hour specific time point collection of Pain and General Pain questions for USUBJID=. All original results are represented in QSORRES, which is then transformed into a standard numeric rating QSSTRESN for the verbal rating scale 5-point, which is then also copied to a standard character value in QSSTRESC. Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSORRESU QSSTRESC QSSTRESN QSSTRESU QSMETHOD VERBAL PR01 - Pain 1 STUDYX QS 1 PR01001 NO 0 0 RATING SCALE 5-POINT 2 STUDYX QS 3 STUDYX QS 4 STUDYX QS 5 STUDYX QS 6 STUDYX QS 7 STUDYX QS 8 STUDYX QS 9 STUDYX QS 10 STUDYX QS 11 STUDYX QS 12 STUDYX QS 2 PR PR PR PR PR PR PR PR PR PR PR01011 PR01 - Starting Pain at Least 1/2 Gone PR01 - Pain PR01 - Starting Pain at Least 1/2 Gone PR01 - Pain PR01 - Starting Pain at Least 1/2 Gone PR01 - Pain PR01 - Starting Pain at Least 1/2 Gone PR01 - Was there Perceptible Pain PR01 - Time to Perceptible Pain PR01 - Was there Meaningful Pain PR01 - Time to Meaningful N N NO 0 0 N N SOME Y Y A LOT OF Y Y Y Y MIN MIN Y Y 360 MIN MIN VERBAL RATING SCALE 5-POINT VERBAL RATING SCALE 5-POINT VERBAL RATING SCALE 5-POINT 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 11

12 Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSORRESU QSSTRESC QSSTRESN QSSTRESU QSMETHOD Pain Row QSLOC QSEVAL VISITNUM QSDTC QSDY QSTPT QSTPTREF 1 (cont d) BACK SUBJECT T13:00 1 P1H Initial Dose 2 (cont d) BACK SUBJECT T13:00 1 P1H Initial Dose 3 (cont d) BACK SUBJECT T14:00 1 P2H Initial Dose 4 (cont d) BACK SUBJECT T14:00 1 P2H Initial Dose 5 (cont d) BACK SUBJECT T16:00 1 P4H Initial Dose 6 (cont d) BACK SUBJECT T16:00 1 P4H Initial Dose 7 (cont d) BACK SUBJECT T18:00 1 P6H Initial Dose 8 (cont d) BACK SUBJECT T18:00 1 P6H Initial Dose 9 (cont d) BACK SUBJECT T18:00 1 P6H Initial Dose 10 (cont d) BACK SUBJECT T18:00 1 P6H Initial Dose 11 (cont d) BACK SUBJECT T18:00 1 P6H Initial Dose 12 (cont d) BACK SUBJECT T18:00 1 P6H Initial Dose The data range text and numeric values for data collection values need to be populated in SUPPQS. These data range values for Pain are mapped to SUPPQS domain as follows. The standard terminology for QNAM and QLABEL are listed below. suppqs.xpt STUDYID RDOMAIN USUBJID IDVAR IDVARVAL QNAM QLABEL QVAL QORIG QEVAL STUDYX QS QSSEQ 1 RNGTXTLO Range Text Lo NO CRF STUDYX QS QSSEQ 1 RNGTXTHI Range Text Hi COMPLETE CRF STUDYX QS QSSEQ 1 RNGVALLO Range Value Lo 0 CRF STUDYX QS QSSEQ 1 RNGVALHI Range Value HI 4 CRF STUDYX QS QSSEQ 3 RNGTXTLO Range Text Lo NO CRF STUDYX QS QSSEQ 3 RNGTXTHI Range Text Hi COMPLETE CRF STUDYX QS QSSEQ 3 RNGVALLO Range Value Lo 0 CRF STUDYX QS QSSEQ 3 RNGVALHI Range Value HI 4 CRF STUDYX QS QSSEQ 5 RNGTXTLO Range Text Lo NO CRF STUDYX QS QSSEQ 5 RNGTXTHI Range Text Hi COMPLETE CRF STUDYX QS QSSEQ 5 RNGVALLO Range Value Lo 0 CRF STUDYX QS QSSEQ 5 RNGVALHI Range Value HI 4 CRF STUDYX QS QSSEQ 7 RNGTXTLO Range Text Lo NO CRF STUDYX QS QSSEQ 7 RNGTXTHI Range Text Hi COMPLETE CRF STUDYX QS QSSEQ 7 RNGVALLO Range Value Lo 0 CRF STUDYX QS QSSEQ 7 RNGVALHI Range Value HI 4 CRF 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 12

13 4 SDTM Mapping Strategy Pain specific mapping strategy: This section is used 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. QSCAT Pain QSTESTCD/QSTEST Proposed Terminology QSTESTCD QSTEST PR01001 PR01 - Pain PR01002 PR01 - Average Pain PR01003 PR01 - Pain Minimum PR01004 PR01 - Pain Maximum PR01005 PR01 - Pain Least PR01006 PR01 - Pain Worst PR01007 PR01 - Starting Pain at Least 1/2 Gone PR01008 PR01 - Was there Perceptible Pain PR01009 PR01 - Time to Perceptible Pain PR01010 PR01 - Was there Meaningful Pain PR01011 PR01 - Time to Meaningful Pain QSMETHOD VERBAL RATING SCALE 5-POINT SUPPQS QVAL value standardization for data range text values QNAM QVAL RNGTXTLO NO RNGTXTHI COMPLETE QSCAT= QSMETHOD = VERBAL RATING SCALE 5-POINT QSTEST = Pain QSORRES QSSTRESC QSSTRESN NO 0 0 A LITTLE 1 1 SOME Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 13

14 A LOT OF 3 3 COMPLETE Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 14

15 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 EVLINTTX Evaluation Time Reference Description QS MOVETYP Movement QS End of Document 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 15