Linguistic validation of the simplified Chinese version of the US National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™)
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-CTCAE™) into Simplified Chinese for use in Singapore. All 124 items of the English source PRO-CTCA...
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| creator | Kkf, Cheng Mitchell, S A Chan, N Ang, E Tam, W Kanesvaran, R |
| description | 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-CTCAE™) into Simplified Chinese for use in Singapore.
All 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 |
| doi_str_mv | 10.1186/s12885-020-07631-5 |
| format | Article |
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All 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.
A 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.
PRO-CTCAE-Simplified Chinese has been successfully developed and linguistically validated in a sample of cancer patients residing in Singapore.</description><identifier>ISSN: 1471-2407</identifier><identifier>EISSN: 1471-2407</identifier><identifier>DOI: 10.1186/s12885-020-07631-5</identifier><identifier>PMID: 33243173</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Acculturation ; Adverse Drug Reaction Reporting Systems - standards ; Asian Continental Ancestry Group ; Bilingualism ; Breast cancer ; Cancer ; Cancer patients ; Cancer therapies ; Chinese languages ; Clinical trials ; Cognitive ability ; Decision making ; Drug-Related Side Effects and Adverse Reactions - diagnosis ; Female ; Humans ; Interpreters ; Interviews ; Libraries ; Linguistics ; Linguistics - methods ; Male ; Medical research ; Methods ; Middle Aged ; National Cancer Institute (U.S.) ; Outcome and process assessment (Health Care) ; Patient Reported Outcome Measures ; Patients ; Surveys ; Terminology ; Translations ; United States</subject><ispartof>BMC cancer, 2020-11, Vol.20 (1), p.1153, Article 1153</ispartof><rights>COPYRIGHT 2020 BioMed Central Ltd.</rights><rights>2020. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>The Author(s) 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c562t-c2b791520cfe4ed2699f44829ceae27095a88f1d2d3968e830260538627a9aab3</citedby><cites>FETCH-LOGICAL-c562t-c2b791520cfe4ed2699f44829ceae27095a88f1d2d3968e830260538627a9aab3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7690028/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7690028/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33243173$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kkf, Cheng</creatorcontrib><creatorcontrib>Mitchell, S A</creatorcontrib><creatorcontrib>Chan, N</creatorcontrib><creatorcontrib>Ang, E</creatorcontrib><creatorcontrib>Tam, W</creatorcontrib><creatorcontrib>Kanesvaran, R</creatorcontrib><title>Linguistic validation of the simplified Chinese version of the US National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™)</title><title>BMC cancer</title><addtitle>BMC Cancer</addtitle><description>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-CTCAE™) into Simplified Chinese for use in Singapore.
All 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.
A 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.
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Mitchell, S A ; Chan, N ; Ang, E ; Tam, W ; Kanesvaran, R</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c562t-c2b791520cfe4ed2699f44829ceae27095a88f1d2d3968e830260538627a9aab3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Acculturation</topic><topic>Adverse Drug Reaction Reporting Systems - standards</topic><topic>Asian Continental Ancestry Group</topic><topic>Bilingualism</topic><topic>Breast cancer</topic><topic>Cancer</topic><topic>Cancer patients</topic><topic>Cancer therapies</topic><topic>Chinese languages</topic><topic>Clinical trials</topic><topic>Cognitive ability</topic><topic>Decision making</topic><topic>Drug-Related Side Effects and Adverse Reactions - diagnosis</topic><topic>Female</topic><topic>Humans</topic><topic>Interpreters</topic><topic>Interviews</topic><topic>Libraries</topic><topic>Linguistics</topic><topic>Linguistics - methods</topic><topic>Male</topic><topic>Medical research</topic><topic>Methods</topic><topic>Middle Aged</topic><topic>National Cancer Institute (U.S.)</topic><topic>Outcome and process assessment (Health Care)</topic><topic>Patient Reported Outcome Measures</topic><topic>Patients</topic><topic>Surveys</topic><topic>Terminology</topic><topic>Translations</topic><topic>United States</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kkf, Cheng</creatorcontrib><creatorcontrib>Mitchell, S A</creatorcontrib><creatorcontrib>Chan, N</creatorcontrib><creatorcontrib>Ang, E</creatorcontrib><creatorcontrib>Tam, W</creatorcontrib><creatorcontrib>Kanesvaran, R</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In Context: Science</collection><collection>ProQuest Central (Corporate)</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMC cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kkf, Cheng</au><au>Mitchell, S A</au><au>Chan, N</au><au>Ang, E</au><au>Tam, W</au><au>Kanesvaran, R</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Linguistic validation of the simplified Chinese version of the US National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™)</atitle><jtitle>BMC cancer</jtitle><addtitle>BMC Cancer</addtitle><date>2020-11-26</date><risdate>2020</risdate><volume>20</volume><issue>1</issue><spage>1153</spage><pages>1153-</pages><artnum>1153</artnum><issn>1471-2407</issn><eissn>1471-2407</eissn><abstract>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-CTCAE™) into Simplified Chinese for use in Singapore.
All 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.
A 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.
PRO-CTCAE-Simplified Chinese has been successfully developed and linguistically validated in a sample of cancer patients residing in Singapore.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>33243173</pmid><doi>10.1186/s12885-020-07631-5</doi><oa>free_for_read</oa></addata></record> |
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| subjects | Acculturation Adverse Drug Reaction Reporting Systems - standards Asian Continental Ancestry Group Bilingualism Breast cancer Cancer Cancer patients Cancer therapies Chinese languages Clinical trials Cognitive ability Decision making Drug-Related Side Effects and Adverse Reactions - diagnosis Female Humans Interpreters Interviews Libraries Linguistics Linguistics - methods Male Medical research Methods Middle Aged National Cancer Institute (U.S.) Outcome and process assessment (Health Care) Patient Reported Outcome Measures Patients Surveys Terminology Translations United States |
| title | Linguistic validation of the simplified Chinese version of the US National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™) |
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