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Revision History

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

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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

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• NCI's "Terms of Use"

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• . PRO-CTCAE Measurement System content should be downloaded using the "Instrument & Form Builder". https://healthcaredelivery.cancer.gov/

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• prot-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

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• Sept 29;106(9

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• )).

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

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[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. As a CDISC QRS standard, the instrument name is PRO-CTCAE V1.0 VERSION DATE 4/26/2020, as provided in this supplement. As an item library, sponsors may select items from the overall library as a subset of items with the same CDISC controlled terminology as appropriate for the condiction being studied. It is the users responsibility to identify the subset of items used from the ovearll PRO-CTCAE V1.0 Item Library (Version 1.0) for this use case. The subsetted PRO-CTCAE V1.0 VERSION DATE 4/26/2020 user's instrument can be named based on the user's descretion when they  they identify the specifc items being used.
2. The symptomatic AE being measured by a given item (e.g., the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 Symptom Term Symptom Term represented on the CRF corresponding to a given item) is stored in the SUPPQS dataset with the QNAM = "QSSYMTRM". This will match the term identified in the PRO-CTCAE V1.0 Item Library (Version 1.0).
3. Administration of PRO-CTCAE V1.0 VERSION DATE 4/26/2020 may be conducted 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 may be represented as a supplemental qualifier with QNAM = "QSLANG". Reference the  the PRO-CTCAE V1.0 website for a list of available translations at: https://healthcaredelivery.cancer.gov/pro-ctcae/.

5. The PRO-CTCAE V1.0 VERSION DATE 4/26/2020, QSORRES is populated with the text description and 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 at: 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 rated as follows:
      1. Items rated on a binary response scale and scored from "0-1" (e.g., "0 = “No” and "1" = “Yes”);
      2. Items rated on a polytomous response scale and scored from "0-1" (e.g., "0" = “No”, "1 " =“Yes”, and “Not applicable”); or
      3. Items rated on a polytomous response scale and scored from "0-1" (e.g., "0" = “No”, "1" = “Yes”, “Not sexually active”, and “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             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  branching approach at: https://healthcaredelivery.cancer.gov/pro-ctcae/faqs.html.

   1. These branching items on the PRO-CTCAE V1.0 VERSION DATE 4/26/2020 may be logically skipped per the instrument instructions. Only one of the 2 oxygen saturation scales (RSTESTCD = "NEWS102" or "NEWS103") is completed for each subject. The other will be treated as a logically skipped item. In addition, item RSTESTCD = "NEWS104A" is only completed when the response to RSTESTCD = "NEWS104" is the amount of oxygen received (in L/min)For example, If the item "In the last 7 days, how OFTEN did you have PAIN IN THE ABDOMEN (BELLY AREA)? (QSTESTCD = "PT01017A") is answered as "Never". The related symptom items for severity and interference are logically skipped (QSTESTCD = "PT01017B" and "PT01017C"), since the symptom did not occur. A record is created in rsqs.xpt for all items. When an item is considered a logically skipped item, it is represented as follows:

      1. RSSTAT = "NOT DONE".        

      2. RSREASND = "LOGICALLY SKIPPED ITEM".
         

      3. RSORRES, RSSTRESC, and RSSTRESN are set to null (missing)is set to null (missing).

      4. RSSTRESC and RSSTRESN are represented with the numeric value 0 as specified in the scoring criteria. Please reference the FAQ "How is the PRO-CTCAE scored" on the website 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. 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.

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

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

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

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

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

--TESTCD = "PT01066A" --TEST = "PT01-Achieve/Maintain Erection Severity"

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--TESTCD = "PT01071A" --TEST = "PT01-Pain w/Sexual Intercourse Severity"

--TESTCD = "PT01067A" --TEST = "PT01-Ejaculation Frequency"

--TESTCD = "PT01069A" --TEST = "PT01-Delayed Orgasm Presence"

--TESTCD = "PT01070A" --TEST = "PT01-Unable to Have Orgasm Presence"

--TESTCD = "PT01036A" --TEST = "PT01-Radiation Skin Reaction Severity"

--TESTCD = "PT01057A" --TEST = "PT01-Irregular Menstrual Period Presence"

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--TESTCD = "PT01079A" --TEST = "PT01-Pain&Swelling at Inj Site Presence"

5 Supplemental Qualifier Name Codes

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