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Information for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

Title

Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Item Library Version 1.0 Version Date 4/26/2020 (PRO-CTCAE V1.0 VERSION DATE 4/26/2020)

CDISC ReferenceQuestionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

PRO-CTCAE V1.0 VERSION DATE 4/26/2020

QRS Permission StatusApproved
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusDRAFT
Date2021-08-12
NotesThis 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


DateVersion
2021-08-121.0 Draft

© 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Item Library Version 1.0 Version Date 4/26/2020 (PRO-CTCAE V1.0 VERSION DATE 4/26/2020) instrument.

CDISC does not modify QRS instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found at the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All instrument documentation can be found on the CDISC web site at: https://www.cdisc.org/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC web site at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG 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.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected nor how to conduct clinical assessments or protocols.

Although FDA has provided input with regard to this supplement, this input does not constitute FDA endorsement of any particular instrument.

2 Copyright Status

While the PRO-CTCAE is in the public domain, this measure is copyrighted and available from the the Division of Cancer Control and Population Sciences in the NATIONAL CANCER INSTITUTE (NCI) at the NATIONAL INSTITUTES OF HEALTH (NIH) (TBD). CDISC has included the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 as part of CDISC Data Standards. Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

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 the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, for the approval to include the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 in the CDISC data standards.

Reference for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020:

The PRO-CTCAE trademark items and information herein were developed by the Division of Cancer Control and Population Sciences in the NATIONAL CANCER INSTITUTE at the NATIONAL INSTITUTES OF HEALTH, in Bethesda, Maryland, U.S.A. Use of the PRO-CTCAE is subject to NCI’s "Terms of Use" and the "Instrument & Form Builder". https://healthcaredelivery.cancer.gov/pro-ctcae/. Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O'Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).J Natl Cancer Inst 2014 Sep 29;106(9). pii: dju244. doi: 10.1093/jnci/dju244.

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 are listed below.

The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 a patient-reported outcome (PRO) instrument developed to capture symptomatic adverse events in patients on cancer clinical trials. The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 was designed to be used in conjunction with the Common Terminology Criteria for Adverse Events (CTCAE).[1] It consists of an item library rather than a static/fixed question type of instrument. You should use the form builder at: https://healthcaredelivery.cancer.gov/pro-ctcae/instrument.html and instructions provided by NCI to select the items to implement in your clinical study. The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 includes multiple choice questions on the frequency. severity, interference, presence/absence and amount of adverse events.The items are rated on a 5-point scale ("0-4"). Total scoring instructions have not yet been developed.

[1] National Institutes of Health – National Cancer Institute, Division of Cancer Control & Population Sciences.  (2017, July 2) https://healthcaredelivery.cancer.gov/pro-ctcae/overview.html

  1. The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 is an item library rather than a static/fixed instrument. You should use the form builder at: https://healthcaredelivery.cancer.gov/pro-ctcae/instrument.html and instructions provided by NCI to select the items to implement in your clinical study.
  2. The symptomatic AE being measured by a given item (e.g., the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 Symptom Term corresponding to a given item) is stored in SUPPQS QNAM=".QSSYMTRM".
  3. Administration of PRO-CTCAE V1.0 VERSION DATE 4/26/2020 via different modes, including screen-based, interactive voice response, and paper, offers flexibility for patients and for study operations personnel.
  4. The language in which the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 was administered (e.g., English, Spanish, Japanese) is collected with the Form Builder application and is represented as a supplemental qualifier with QNAM="QSLANG". Reference the  PRO-CTCAE website for a list of available translations.

  5. For the PRO-CTCAE V1.0 VERSION DATE 4/26/2020, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN   Please reference the PRO-CTCAE website for more details on the scoring criteria: https://healthcaredelivery.cancer.gov/pro-ctcae/faqs.html The responses for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 are as follows:

    1. Depending on the symptomatic AE being measured, items assessing symptom presence/absence are … 
      1. Rated on a binary response scale and scored from "0-1" (e.g., "0 = “No” and "1" = “Yes”);
      2. Rated on a polytomous response scale and scored from "0-1" (e.g., "0" = “No”, "1 " =“Yes”, and NULL= “Not applicable”); or
      3. Rated on a polytomous response scale and scored from "0-1" (e.g., "0" = “No”, "1" = “Yes”, NULL= “Not sexually active”, and NULL= “Prefer not to answer”).
    2. Items assessing symptom amount are rated on a 5-point Likert scale and scored from "0-4" (e.g., "0" = “Not at all”, "1" = “A little bit”, "2" = “Somewhat”, "3" = “Quite a bit”, and             '4 ' = “Very much”).
    3. Items assessing symptom frequency are rated on a 5-point Likert scale and are scored from "0-4" (e.g., "0" = “Never”, "1" = “Rarely”, "2" =“Occasionally”, "3" = “Frequently”, and "4" = “Almost constantly”).
    4. Items assessing symptom severity are rated on a 5-point Likert scale and are scored from "0-4" (e.g., "0" = “None”, "1" = “Mild”, "2" = “Moderate”, "3" = “Severe”, and "4" = “Very severe”).
    5. Items assessing symptom interference are rated on a 5-point Likert scale and are scored from "0-4" (e.g., "0" = “Not at all”, "1" = “A little bit”, "2" = “Somewhat”, "3 ' = “Quite a bit”, and "4" = “Very much”). 
    6. Item-level scores are not combined (e.g., no total score nor symptom-specific scores are calculated).
  6. Conditional branching is used in the conduct of the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 for symptom terms that have two or more items. The logic branches from frequency, then to severity, then to interference. For example, if frequency is > (greater than) never, you next pose the severity question, and if severity>none, you pose the interference question. Please reference the PRO-CTCAE website for more details on the conditional branching  approach at: https://healthcaredelivery.cancer.gov/pro-ctcae/faqs.html.

  7. The time period of evaluation for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 is populated in the QSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The recommended evaluation interval for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 is the past 7 days. Please reference the PRO-CTCAE website for more details on the evaluation interval at: https://healthcaredelivery.cancer.gov/pro-ctcae/faqs.html.

  8. If the instrument standards currently being developed includes logically skipped items, insert:  'Some items on the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 may be logically skipped per the instrument instructions.  Language to be used for this assumption is currently under review.'

    This language is currently under review. Remove this point if it does not apply.:  Some items on the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 may be logically skipped per the instrument instructions.  Responses for logically skipped items should be (1) recorded and/or scored according to the instructions provided in the instrument’s user manual, scoring manual, or other documentation provided by the instrument developer and (2) included in the submission dataset.  If such instructions are not available, then records for logically skipped items should be included in the submission dataset with:
    ·       QSSTAT = NOT DONE;
    ·       QSREASND = LOGICALLY SKIPPED ITEM; and
    ·       QSORRES, QSSTRESC, and QSSTRESN all set to null
    When submitting data to FDA or some other regulatory authority to support regulatory review of a medical product, if the electronic data collection system is not capable of automatically populating records for logically skipped items, these records should be post-populated prior to submission and the sponsor will need to explain this in the corresponding reviewer's guide.
  9. Terminology
    1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the qualifier, timing, and result fields is provided in Section 4, SDTM Mapping Strategy.

3.2 Example for the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 QS Domain Model

The PRO-CTCAE V1.0 VERSION DATE 4/26/2020 example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for one subject collected at the baseline visit for a PRO-CTCAE V1.0 VERSION DATE 4/26/2020 instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results are represented with preferred terminology in QSORRES. This result is then transformed into the standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC.

We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.


The table represents the questions from the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 instrument.

Dataset Wrapper Debug Message

Row captions have been provided, but there doesn't seem to be a dataset to which the row captions would apply.

Rows 13-14:Questions 11 and 12 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Question 12 would not appear in the actual dataset and has result values of "XXX".
Rows 15-16:Questions 13 and 14 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Question 14 would not appear in the actual dataset and has result values of "XXX".
Row 33:The total score does not have an evaluation interval value represented, since there is a mixture of evaluation interval values with questions 13 and 14 that differ from the remaining questions on the CRF.
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The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

STUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIG









4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

QSSCAT alignment with QSTESTCD

As stated in Section 3.1 assumptions, the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 is grouped into subcategories. The table below includes the subcategory names along with the applicable question numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

QSSCATQSTESTCD
ORALPT01001A - PT01006A
GASTROINTESTINALPT01007A - PT01018B
RESPIRATORYRPT01019A - PT01021A
CARDIO/CIRCULATORYPT01022A - PT01023B
CUTANEOUSPT01024A - PT01038A
NEUROLOGICALPT01039A - PT01040A
VISUAL/PERCEPTUALPT01040B - PT01045A
ATTENTION/MEMORYPT01046A - PT01047B
PAINPT01048A - PT01051C
SLEEP/WAKEPT01052A - PT01053B
MOODPT01054A - PT01056C
GYNECOLOGIC/URINARYPT01057A - PT01065B
SEXUALPT01066A - PT01071A
MISCELLANEOUSPT01072A - PT01080A
OTHER SYMPTOMPT01081 - PT01091B


5 Supplemental Qualifier Name Codes

The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires (SUPPQS) special purpose dataset.

QNAMQLABELQVAL
QSLANGQuestionnaire LanguageENGLISH


CHINESE


CZECH


DANISH


DUTCH


FRENCH


GERMAN


GREEK


HUNGARIAN


ITALIAN


JAPANESE


KOREAN


POLISH


PORTUGUESE


RUSSIAN


SPANISH
QSSYMTRM
Symptom TermDRY MOUTH


DIFFICULTY SWALLOWING


MOUTH/THROAT SORES


CRACKING AT THE CORNERS OF THE MOUTH (CHEILOSIS/CHEILITIS)


VOICE QUALITY CHANGES


HOARSENESS


TASTE CHANGES


DECREASED APPETITE


NAUSEA


VOMITING


HEARTBURN


GAS


BLOATING


HICCUPS


CONSTIPATION


DIARRHEA/DIARRHOEA


ABDOMINAL PAIN


FECAL INCONTINENCE


SHORTNESS OF BREATH


COUGH


WHEEZING


SWELLING


HEART PALPITATIONS


RASH


SKIN DRYNESS


ACNE


HAIR LOSS


ITCHING


HIVES


HAND-FOOT SYNDROME


NAIL LOSS


NAIL RIDGING


NAIL DISCOLORATION


SENSITIVITY TO SUNLIGHT


BED/PRESSURE SORES


RADIATION SKIN REACTION


SKIN DARKENING


STRETCH MARKS


NUMBNESS & TINGLING


DIZZINESS


BLURRED VISION


FLASHING LIGHTS


VISUAL FLOATERS


WATERY EYES


RINGING IN EARS


CONCENTRATION


MEMORY


GENERAL PAIN


HEADACHE


MUSCLE PAIN


JOINT PAIN


INSOMNIA


FATIGUE


ANXIOUS


DISCOURAGED


SAD


IRREGULAR PERIODS/VAGINAL BLEEDING


MISSED EXPECTED MENSTRUAL PERIOD


VAGINAL DISCHARGE


VAGINAL DRYNESS


PAINFUL URINATION


URINARY URGENCY


URINARY FREQUENCY


CHANGE IN USUAL URINE COLOR


URINARY INCONTINENCE


ACHIEVE AND MAINTAIN ERECTION


EJACULATION


DECREASED LIBIDO


DELAYED ORGASM


UNABLE TO HAVE ORGASM


PAIN W/SEXUAL INTERCOURSE


BREAST SWELLING AND TENDERNESS


BRUISING


CHILLS


INCREASED SWEATING


DECREASED SWEATING


HOT FLASHES/FLUSHES


NOSEBLEED


PAIN AND SWELLING AT INJECTION SITE


BODY ODOR


OTHER SYMPTOM


End of Document

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