Karnofsky Performance Status Scale (KPS Scale)

Transcription

1 Karnofsky Performance Status Scale (KPS Scale) 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 Karnofsky performance status scale (KPSS) Draft Karnofsky performance status scale (KPSS)

2 1 Introduction This document describes the CDISC implementation of the Karnofsky Performance Status Scale (KPS Scale) questionnaire, a standard questionnaire administered on a CRF that is typically used in clinical trials to measure pain response. The KPS Scale 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 This instrument is in the public domain. CDISC has included the Karnofsky Performance Status Scale (KPS Scale) 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. 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. CDISC has developed this documentation at no cost to users of the instrument 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 for the QS domain from the SDTMIG apply for this supplemental implementation guide including those referenced in the CDISC notes. Additionally, the following assumption applies to the KARNOFSKY PERFORMANCE STATUS SCALE: 1. Karnofsky Performance Status Scale (KPSS): KPSS allows patients to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the Karnofsky score, the worse the survival for most serious illnesses. 2. 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. 3. The evaluator of the questionnaire is stored in QSEVAL and for the KPSS form the INVESTIGATOR provides the evaluation. 4. 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 Karnofsky Performance Status Scale Domain Model The KPSS 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 1: KARNOFSKY PERFORMANCE STATUS SCALE (KPSS) This example shows data from one subject collected at three visits for a KPSS questionnaire. The example uses standard controlled terminology for QSTESTCD, QSTEST, QSCAT and QSORRES for the KPSS measure. Rows 1-3: Represent the question from the KPSS Form for three visits for SUBJID= 2324-P0001. 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 STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC QSSTRESN QSSTRESU KPSS-Karnofsky KPS 1 STUDYX QS 1 KPSS01 P0001 Performance Status Scale Disabled; requires special care and assistance % KPSS-Karnofsky KPS Requires considerable assistance and frequent 2 STUDYX QS 2 KPSS01 P0001 Performance Status Scale medical care % KPSS-Karnofsky KPS Requires occasional assistance, but is able to care 3 STUDYX QS 3 KPSS01 P0001 Performance Status Scale for most of his personal needs % Row QSEVAL VISITNUM QSDTC 1 (cont) INVESTIGATOR (cont) INVESTIGATOR (cont) INVESTIGATOR 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 2324-P0001 QSSEQ 1 RNGTXTLO Range Text Lo Dead CRF STUDY01 QS 2324-P0001 QSSEQ 1 RNGTXTHI Range Text Hi Normal no complaints; no evidence of disease. CRF STUDY01 QS 2324-P0001 QSSEQ 1 RNGVALLO Range Value Lo 0 CRF STUDY01 QS 2324-P0001 QSSEQ 1 RNGVALHI Range Value HI 100 CRF STUDY01 QS 2324-P0001 QSSEQ 2 RNGTXTLO Range Text Lo Dead CRF STUDY01 QS 2324-P0001 QSSEQ 2 RNGTXTHI Range Text Hi Normal no complaints; no evidence of disease. CRF STUDY01 QS 2324-P0001 QSSEQ 2 RNGVALLO Range Value Lo 0 CRF STUDY01 QS 2324-P0001 QSSEQ 2 RNGVALHI Range Value HI 100 CRF STUDY01 QS 2324-P0001 QSSEQ 3 RNGTXTLO Range Text Lo Dead CRF STUDY01 QS 2324-P0001 QSSEQ 3 RNGTXTHI Range Text Hi Normal no complaints; no evidence of disease. CRF STUDY01 QS 2324-P0001 QSSEQ 3 RNGVALLO Range Value Lo 0 CRF STUDY01 QS 2324-P0001 QSSEQ 3 RNGVALHI Range Value HI 100 CRF 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 4

5 4 SDTM Mapping Strategy KPSS 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= KPSS01 QSTEST= KPSS-Karnofsky Performance Status QSORRES QSSTRESC QSSTRESN QSSTRESU Normal no complaints; no evidence of disease % Able to carry on normal activity; minor signs or symptoms of disease % Normal activity with effort; some signs or symptoms of disease % Cares for self; unable to carry on normal activity or to do active work % Requires occasional assistance, but is able to care for most of his personal needs % Requires considerable assistance and frequent medical care % Disabled; requires special care and assistance % Severely disabled; hospital admission is indicated although death not imminent % Very sick; hospital admission necessary; active supportive treatment necessary % Moribund; fatal processes progressing rapidly % Dead 0 0 % 2012 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 5

6 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 6