Abstract

BackgroundThe aim of this study was to translate and linguistically validate the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) into Simplified Chinese for use in Singapore.MethodsAll 124 items of the English source PRO-CTCAE item library were translated into Simplified Chinese using internationally established translation procedures. Two rounds of cognitive interviews were conducted with 96 cancer patients undergoing adjuvant treatment to determine if the translations adequately captured the PRO-CTCAE source concepts, and to evaluate comprehension, clarity and ease of judgement. Interview probes addressed the 78 PRO-CTCAE symptom terms (e.g. fatigue), as well as the attributes (e.g. severity), response choices, and phrasing of ‘at its worst’. Items that met the a priori threshold of ≥20% of participants with comprehension difficulties were considered for rephrasing and retesting. Items where < 20% of the sample experienced comprehension difficulties were also considered for rephrasing if better phrasing options were available.ResultsA majority of PRO-CTCAE-Simplified Chinese items were well comprehended by participants in Round 1. One item posed difficulties in ≥20% and was revised. Two items presented difficulties in < 20% but were revised as there were preferred alternative phrasings. Twenty-four items presented difficulties in < 10% of respondents. Of these, eleven items were revised to an alternative preferred phrasing, four items were revised to include synonyms. Revised items were tested in Round 2 and demonstrated satisfactory comprehension.ConclusionsPRO-CTCAE-Simplified Chinese has been successfully developed and linguistically validated in a sample of cancer patients residing in Singapore.

Highlights

  • The aim of this study was to translate and linguistically validate the U.S National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAETM) into Simplified Chinese for use in Singapore

  • Of the 790 adverse events listed in the CTCAE, 78 symptomatic adverse events that are amenable to patient self-reporting were selected for inclusion in patientreported outcomes (PROs)-CTCAE [2, 6]

  • The backward translations were compared with the original English PRO-CTCAE to identify discrepancies

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Summary

Introduction

The aim of this study was to translate and linguistically validate the U.S National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAETM) into Simplified Chinese for use in Singapore. The Patient-Reported Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAETM), was developed by the US National Cancer Institute (NCI), to be used in conjunction with the Common Terminology Criteria for Adverse Events (CTCAE) to facilitate patient self-reporting of symptomatic adverse effects. The most recent version of the clinician-based CTCAE, version 5, is a compendium of 790 discrete adverse events each of which is defined and graded using an ordinal severity scale [3]. Of the 790 adverse events listed in the CTCAE, 78 symptomatic adverse events that are amenable to patient self-reporting (e.g. pain, fatigue) were selected for inclusion in PRO-CTCAE [2, 6]

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