PRO-CTCAE Version 1.0 Release Notes

English

Adjusted labeling of English PRO-CTCAE item library to include “(Universal)” following validation testing in USA, Australia, Canada, and the UK to create a single, harmonized version.

Spanish

Adjusted labeling of Spanish PRO-CTCAE item library to include “(Universal)” following validation testing in USA, Spain, and Chile to create a single, harmonized version.

Russian

Adjusted labeling of Russian PRO-CTCAE item library to include “(Universal)” following validation testing in Russia, Ukraine, and Israel to create a single, harmonized version.

German

Adjusted labeling of German PRO-CTCAE item library to include “(Universal)” following validation testing in Germany, Austria, and Switzerland to create a single, harmonized version.

Chinese (Traditional)

Adjusted labeling of Chinese (Traditional) PRO-CTCAE item library to include “(Universal)” following validation testing in USA, Taiwan, and Hong Kong to create a single, harmonized version.

Arabic

• PRO-CTCAE Item 18. Symptom Term: Fecal incontinence: Parenthetical (الغائط) added to improve comprehension following validation testing in USA, Saudi Arabia, and Morocco.
• PRO-CTCAE Item 22. Symptom Term: Swelling: Parenthetical (انتفاخ) added to improve comprehension following validation testing in USA, Saudi Arabia, and Morocco.
• PRO-CTCAE Item 32. Symptom Term: Nail Ridging: Parenthetical (خطوط) added to improve comprehension following validation testing in USA, Saudi Arabia, and Morocco.
• PRO-CTCAE Item 70. Symptom Term: Unable to have orgasm: Minor grammatical adjustment made to emphasize universality of the question to all respondents regardless of gender following validation testing in USA, Saudi Arabia, and Morocco.
• Other Symptoms: Correction of typographical errors in the first question in 'Other Symptoms' section.

Tamil

Correction of typographical errors in item 31a (Symptom term: nail loss) and item 32a (Symptom term: nail ridging).

Korean

Correction of minor typographical errors in items 11, 55, and 64.

Arabic

Correction of minor typographical error in the English anchoring content in the 'Other Symptoms' question.

Hebrew

Correction of minor typographical error in the English anchoring content in the 'Other Symptoms' question.

Hebrew

Respondent instructions corrected to include the phrase “over the past 7 days”.

Portuguese (Brazil)

Correction of typographical error in item 28.

Italian

Correction of typographical error in item 64.

English

Correction of a minor typographical error in item 57.

French (Belgium, France and Switzerland)

Correction of typographical error in item 76 and in the response choices for the 'Other Symptoms' questions.

Portuguese (Brazil)

Correction of typographical error in respondent instructions.

Turkish

Correction of typographical error in item 52b.

Czech

Correction of a minor typographical error in item 51a.

Danish

Correction to the questions soliciting additional symptoms to include the recall period of "In the last 7 days" to the questions soliciting additional symptoms.

Chinese (Traditional)

Respondent instructions rephrased to be inclusive of electronic administration.

Previous respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please check or mark an X in the one box that best describes your experiences over the past 7 days…

Revised respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please select the one response that best describes your experiences over the past 7 days.

Minor phrasing revisions to address findings from linguistic validation study performed in Hong Kong:

• PRO-CTCAE Item 35. Symptom Term: Bed/pressure sores:
  Parenthetical added to improve comprehension.
• PRO-CTCAE Item 51. Symptom Term: Joint pain:
  Elaboration of the term 'elbows' added to improve comprehension.

Multiple Languages

Languages

Chinese (Simplified); Czech; Danish; Dutch (for Belgium and the Netherlands); French (Canada); French (Belgium, France, and Switzerland); German; Hungarian; Japanese; Korean; Malay; Polish; Portuguese (Brazil); Portuguese (Portugal); Romanian; Spanish (Universal); Turkish

Updates

Respondent instructions rephrased to be inclusive of electronic administration.

Previous respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please check or mark an X in the one box that best describes your experiences over the past 7 days…

Revised respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please select the one response that best describes your experiences over the past 7 days.

Italian

Respondent instructions rephrased to be inclusive of electronic administration.

Previous respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please check or mark an X in the one box that best describes your experiences over the past 7 days…

Revised respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please select the one response that best describes your experiences over the past 7 days…

Correction of minor typographical errors in items 9a, 9b, 12a, 21a, 29a, 30a, 31a, 48a, 48b, 48c, 51a, 51b, 51c, 52a, 52b, 53b, and 75b.

English (Universal)

Respondent instructions rephrased to be inclusive of electronic administration.

Previous respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please check or mark an X in the one box that best describes your experiences over the past 7 days…

Revised respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please select the one response that best describes your experiences over the past 7 days.

Greek

Respondent instructions rephrased to be inclusive of electronic administration.

Previous respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please check or mark an X in the one box that best describes your experiences over the past 7 days…

Revised respondent instructions: As individuals go through treatment for their cancer they sometimes experience different symptoms and side effects. For each question, please select the one response that best describes your experiences over the past 7 days.

Russian (Universal)

Correction of minor typographical errors in items 22b and 65a.

Greek

Correction of typographical error in phrasing of item 44b, the interference item for watery eyes.

English (Universal)

• PRO-CTCAE Item 16. Symptom Term: Diarrhea: UK spelling was added to the item "DIARRHEA/DIARRHOEA"
• PRO-CTCAE Item 75. Symptom Term: Increased sweating: "(Not related to hot flashes)" revised to "(Not related to hot flashes/flushes)" to localize for UK
• PRO-CTCAE Item 77. Symptom Term: Hot flashes: Hot flashes revised to Hot flashes/flushes to localize for UK

Spanish (Universal)

• PRO-CTCAE Item 6. Symptom Term: Hoarseness: Parenthetical (VOZ RONCA) added to improve comprehension
• PRO-CTCAE Item 38. Symptom Term: Stretch marks: Parenthetical (RAYAS O LÍNEAS) added to improve comprehension
• PRO-CTCAE Item 72. Symptom Term: Breast swelling and tenderness: Parenthetical (SENSIBILIDAD AL TOCARLO) added to improve comprehension.