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Bryce B Reeve - One of the best experts on this subject based on the ideXlab platform.
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the association of age literacy and race on completing patient reported outcome measures in pediatric oncology
Quality of Life Research, 2019Co-Authors: Janice S Withycombe, Molly Mcfatrich, Laura C Pinheiro, Mia K Waldron, Justin N. Baker, Lillian Sung, Pamela S. Hinds, Frank G Keller, Jenny W Mack, Bryce B ReeveAbstract:Age is often used to determine when children can begin completing patient-reported outcome (PRO) instruments or transition to adult instruments. This study’s purpose was to determine relationships between literacy, age, and race and their influence on a child’s ability to understand and complete a PRO instrument. The Wide Range Achievement Test was used to evaluate literacy in children and young adults with cancer, participating in a Cognitive Interview for the Pediatric PRO-CTCAE instrument. 140 participants (7–20 years) were recruited from 8 sites. Logistic regression and multivariable liner regression were used to examine relationships among key variables. Higher literacy scores were significantly associated with fewer PRO-CTCAE items being identified as “hard to understand” (p = 0.017). Literacy scores increased with age, but older participants were more likely to fall behind expected reading levels compared with US norms. A 1-year increase in age was associated with a 19% increase in the likelihood for being below the expected WRAT word reading score (OR 1.19; 95% CI 1.06–1.33, p = 0.003). No associations were found between race and literacy. Wide variations in literacy were noted across age groups. All participants were able to complete the Pediatric PRO-CTCAE, although most 7 year olds (63%) required reading assistance. Those with lower literacy skills were able to understand items suggesting that multiple factors may be involved in comprehension (developmental stage, concentration, vocabulary, or prior health experiences). Risk for falling below expected literacy levels increased with age implying a need for literacy consideration for cancer patients.
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Cognitive Interview based validation of the patient reported outcomes version of the common terminology criteria for adverse events in adolescents with cancer
Journal of Pain and Symptom Management, 2017Co-Authors: Bryce B Reeve, Molly Mcfatrich, Laura C Pinheiro, Janice S Withycombe, Justin N. Baker, Lillian Sung, Jennifer W Mack, David R Freyer, Ethan Basch, Mia K WaldronAbstract:Abstract Context The National Cancer Institute created the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to allow direct input on symptomatic adverse events (AEs) from adult patients in oncology trials. Objectives This study sought to determine the youngest age to complete the PRO-CTCAE, evaluated comprehension of PRO-CTCAE among adolescents, tested new items not currently in PRO-CTCAE, and tested a parent-proxy version. Methods From seven pediatric cancer hospitals, 51 adolescents (13–20 years) receiving cancer treatment participated, along with 40 parent proxies. We evaluated 55 AEs from the PRO-CTCAE library (97 questions) and seven new AEs not in PRO-CTCAE that assess symptom frequency, severity, interference, or presence. Questions were distributed across three forms to reduce burden. Cognitive Interviews with retrospective probing were completed in age groups of 13–15 and 16–20 year olds. Proxies were Interviewed independently. Results In general, the 16–20 year olds and the parent proxies were able to understand and complete the PRO-CTCAE and newly designed AE questions. Five PRO-CTCAE terms (bloating of the abdomen, anxiety, flashing lights in front of your eyes, hot flashes, and bed sores) and the wording of the questions about AE severity were challenging for a few adolescents and proxies. The 13–15 year olds had greater challenges completing the PRO-CTCAE. Conclusion This study extends use of the adult PRO-CTCAE for adolescents as young as 16 years and proposes new questions for seven new symptomatic AEs and a parent-proxy version of PRO-CTCAE. Additional testing of the new questions and alternative language for more challenging PRO-CTCAE items is recommended in adults.
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eliciting the child s voice in adverse event reporting in oncology trials Cognitive Interview findings from the pediatric patient reported outcomes version of the common terminology criteria for adverse events initiative
Pediatric Blood & Cancer, 2017Co-Authors: Bryce B Reeve, Molly Mcfatrich, Laura C Pinheiro, Janice S Withycombe, Mia K Waldron, Meaghann S Weaver, Justin N. Baker, Lillian Sung, Jennifer W Mack, Deborah V GibsonAbstract:Background Adverse event (AE) reporting in oncology trials is required, but current practice does not directly integrate the child's voice. The Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being developed to assess symptomatic AEs via child/adolescent self-report or proxy-report. This qualitative study evaluates the child's/adolescent's understanding and ability to provide valid responses to the PRO-CTCAE to inform questionnaire refinements and confirm content validity. Procedure From seven pediatric research hospitals, children/adolescents ages 7–15 years who were diagnosed with cancer and receiving treatment were eligible, along with their parent-proxies. The Pediatric PRO-CTCAE includes 130 questions that assess 62 symptomatic AEs capturing symptom frequency, severity, interference, or presence. Cognitive Interviews with retrospective probing were completed with children in the age groups of 7–8, 9–12, and 13–15 years. The children/adolescents and proxies were Interviewed independently. Results Two rounds of Interviews involved 81 children and adolescents and 74 parent-proxies. Fifteen of the 62 AE terms were revised after Round 1, including refinements to the questions assessing symptom severity. Most participants rated the PRO-CTCAE AE items as “very easy” or “somewhat easy” and were able to read, understand, and provide valid responses to questions. A few AE items assessing rare events were challenging to understand. Conclusions The Pediatric and Proxy PRO-CTCAE performed well among children and adolescents and their proxies, supporting its content validity. Data from PRO-CTCAE may improve symptomatic AE reporting in clinical trials and enhance the quality of care that children receive.
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eliciting the child s voice in adverse event reporting in oncology trials Cognitive Interview findings from the pediatric patient reported outcomes version of the common terminology criteria for adverse events initiative
Pediatric Blood & Cancer, 2017Co-Authors: Bryce B Reeve, Molly Mcfatrich, Laura C Pinheiro, Janice S Withycombe, Mia K Waldron, Meaghann S Weaver, Justin N. Baker, Lillian Sung, Jennifer W Mack, Deborah V GibsonAbstract:Background Adverse event (AE) reporting in oncology trials is required, but current practice does not directly integrate the child's voice. The Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being developed to assess symptomatic AEs via child/adolescent self-report or proxy-report. This qualitative study evaluates the child's/adolescent's understanding and ability to provide valid responses to the PRO-CTCAE to inform questionnaire refinements and confirm content validity. Procedure From seven pediatric research hospitals, children/adolescents ages 7–15 years who were diagnosed with cancer and receiving treatment were eligible, along with their parent-proxies. The Pediatric PRO-CTCAE includes 130 questions that assess 62 symptomatic AEs capturing symptom frequency, severity, interference, or presence. Cognitive Interviews with retrospective probing were completed with children in the age groups of 7–8, 9–12, and 13–15 years. The children/adolescents and proxies were Interviewed independently. Results Two rounds of Interviews involved 81 children and adolescents and 74 parent-proxies. Fifteen of the 62 AE terms were revised after Round 1, including refinements to the questions assessing symptom severity. Most participants rated the PRO-CTCAE AE items as “very easy” or “somewhat easy” and were able to read, understand, and provide valid responses to questions. A few AE items assessing rare events were challenging to understand. Conclusions The Pediatric and Proxy PRO-CTCAE performed well among children and adolescents and their proxies, supporting its content validity. Data from PRO-CTCAE may improve symptomatic AE reporting in clinical trials and enhance the quality of care that children receive.
Mia K Waldron - One of the best experts on this subject based on the ideXlab platform.
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the association of age literacy and race on completing patient reported outcome measures in pediatric oncology
Quality of Life Research, 2019Co-Authors: Janice S Withycombe, Molly Mcfatrich, Laura C Pinheiro, Mia K Waldron, Justin N. Baker, Lillian Sung, Pamela S. Hinds, Frank G Keller, Jenny W Mack, Bryce B ReeveAbstract:Age is often used to determine when children can begin completing patient-reported outcome (PRO) instruments or transition to adult instruments. This study’s purpose was to determine relationships between literacy, age, and race and their influence on a child’s ability to understand and complete a PRO instrument. The Wide Range Achievement Test was used to evaluate literacy in children and young adults with cancer, participating in a Cognitive Interview for the Pediatric PRO-CTCAE instrument. 140 participants (7–20 years) were recruited from 8 sites. Logistic regression and multivariable liner regression were used to examine relationships among key variables. Higher literacy scores were significantly associated with fewer PRO-CTCAE items being identified as “hard to understand” (p = 0.017). Literacy scores increased with age, but older participants were more likely to fall behind expected reading levels compared with US norms. A 1-year increase in age was associated with a 19% increase in the likelihood for being below the expected WRAT word reading score (OR 1.19; 95% CI 1.06–1.33, p = 0.003). No associations were found between race and literacy. Wide variations in literacy were noted across age groups. All participants were able to complete the Pediatric PRO-CTCAE, although most 7 year olds (63%) required reading assistance. Those with lower literacy skills were able to understand items suggesting that multiple factors may be involved in comprehension (developmental stage, concentration, vocabulary, or prior health experiences). Risk for falling below expected literacy levels increased with age implying a need for literacy consideration for cancer patients.
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Cognitive Interview based validation of the patient reported outcomes version of the common terminology criteria for adverse events in adolescents with cancer
Journal of Pain and Symptom Management, 2017Co-Authors: Bryce B Reeve, Molly Mcfatrich, Laura C Pinheiro, Janice S Withycombe, Justin N. Baker, Lillian Sung, Jennifer W Mack, David R Freyer, Ethan Basch, Mia K WaldronAbstract:Abstract Context The National Cancer Institute created the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to allow direct input on symptomatic adverse events (AEs) from adult patients in oncology trials. Objectives This study sought to determine the youngest age to complete the PRO-CTCAE, evaluated comprehension of PRO-CTCAE among adolescents, tested new items not currently in PRO-CTCAE, and tested a parent-proxy version. Methods From seven pediatric cancer hospitals, 51 adolescents (13–20 years) receiving cancer treatment participated, along with 40 parent proxies. We evaluated 55 AEs from the PRO-CTCAE library (97 questions) and seven new AEs not in PRO-CTCAE that assess symptom frequency, severity, interference, or presence. Questions were distributed across three forms to reduce burden. Cognitive Interviews with retrospective probing were completed in age groups of 13–15 and 16–20 year olds. Proxies were Interviewed independently. Results In general, the 16–20 year olds and the parent proxies were able to understand and complete the PRO-CTCAE and newly designed AE questions. Five PRO-CTCAE terms (bloating of the abdomen, anxiety, flashing lights in front of your eyes, hot flashes, and bed sores) and the wording of the questions about AE severity were challenging for a few adolescents and proxies. The 13–15 year olds had greater challenges completing the PRO-CTCAE. Conclusion This study extends use of the adult PRO-CTCAE for adolescents as young as 16 years and proposes new questions for seven new symptomatic AEs and a parent-proxy version of PRO-CTCAE. Additional testing of the new questions and alternative language for more challenging PRO-CTCAE items is recommended in adults.
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eliciting the child s voice in adverse event reporting in oncology trials Cognitive Interview findings from the pediatric patient reported outcomes version of the common terminology criteria for adverse events initiative
Pediatric Blood & Cancer, 2017Co-Authors: Bryce B Reeve, Molly Mcfatrich, Laura C Pinheiro, Janice S Withycombe, Mia K Waldron, Meaghann S Weaver, Justin N. Baker, Lillian Sung, Jennifer W Mack, Deborah V GibsonAbstract:Background Adverse event (AE) reporting in oncology trials is required, but current practice does not directly integrate the child's voice. The Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being developed to assess symptomatic AEs via child/adolescent self-report or proxy-report. This qualitative study evaluates the child's/adolescent's understanding and ability to provide valid responses to the PRO-CTCAE to inform questionnaire refinements and confirm content validity. Procedure From seven pediatric research hospitals, children/adolescents ages 7–15 years who were diagnosed with cancer and receiving treatment were eligible, along with their parent-proxies. The Pediatric PRO-CTCAE includes 130 questions that assess 62 symptomatic AEs capturing symptom frequency, severity, interference, or presence. Cognitive Interviews with retrospective probing were completed with children in the age groups of 7–8, 9–12, and 13–15 years. The children/adolescents and proxies were Interviewed independently. Results Two rounds of Interviews involved 81 children and adolescents and 74 parent-proxies. Fifteen of the 62 AE terms were revised after Round 1, including refinements to the questions assessing symptom severity. Most participants rated the PRO-CTCAE AE items as “very easy” or “somewhat easy” and were able to read, understand, and provide valid responses to questions. A few AE items assessing rare events were challenging to understand. Conclusions The Pediatric and Proxy PRO-CTCAE performed well among children and adolescents and their proxies, supporting its content validity. Data from PRO-CTCAE may improve symptomatic AE reporting in clinical trials and enhance the quality of care that children receive.
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eliciting the child s voice in adverse event reporting in oncology trials Cognitive Interview findings from the pediatric patient reported outcomes version of the common terminology criteria for adverse events initiative
Pediatric Blood & Cancer, 2017Co-Authors: Bryce B Reeve, Molly Mcfatrich, Laura C Pinheiro, Janice S Withycombe, Mia K Waldron, Meaghann S Weaver, Justin N. Baker, Lillian Sung, Jennifer W Mack, Deborah V GibsonAbstract:Background Adverse event (AE) reporting in oncology trials is required, but current practice does not directly integrate the child's voice. The Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being developed to assess symptomatic AEs via child/adolescent self-report or proxy-report. This qualitative study evaluates the child's/adolescent's understanding and ability to provide valid responses to the PRO-CTCAE to inform questionnaire refinements and confirm content validity. Procedure From seven pediatric research hospitals, children/adolescents ages 7–15 years who were diagnosed with cancer and receiving treatment were eligible, along with their parent-proxies. The Pediatric PRO-CTCAE includes 130 questions that assess 62 symptomatic AEs capturing symptom frequency, severity, interference, or presence. Cognitive Interviews with retrospective probing were completed with children in the age groups of 7–8, 9–12, and 13–15 years. The children/adolescents and proxies were Interviewed independently. Results Two rounds of Interviews involved 81 children and adolescents and 74 parent-proxies. Fifteen of the 62 AE terms were revised after Round 1, including refinements to the questions assessing symptom severity. Most participants rated the PRO-CTCAE AE items as “very easy” or “somewhat easy” and were able to read, understand, and provide valid responses to questions. A few AE items assessing rare events were challenging to understand. Conclusions The Pediatric and Proxy PRO-CTCAE performed well among children and adolescents and their proxies, supporting its content validity. Data from PRO-CTCAE may improve symptomatic AE reporting in clinical trials and enhance the quality of care that children receive.
Janice S Withycombe - One of the best experts on this subject based on the ideXlab platform.
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the association of age literacy and race on completing patient reported outcome measures in pediatric oncology
Quality of Life Research, 2019Co-Authors: Janice S Withycombe, Molly Mcfatrich, Laura C Pinheiro, Mia K Waldron, Justin N. Baker, Lillian Sung, Pamela S. Hinds, Frank G Keller, Jenny W Mack, Bryce B ReeveAbstract:Age is often used to determine when children can begin completing patient-reported outcome (PRO) instruments or transition to adult instruments. This study’s purpose was to determine relationships between literacy, age, and race and their influence on a child’s ability to understand and complete a PRO instrument. The Wide Range Achievement Test was used to evaluate literacy in children and young adults with cancer, participating in a Cognitive Interview for the Pediatric PRO-CTCAE instrument. 140 participants (7–20 years) were recruited from 8 sites. Logistic regression and multivariable liner regression were used to examine relationships among key variables. Higher literacy scores were significantly associated with fewer PRO-CTCAE items being identified as “hard to understand” (p = 0.017). Literacy scores increased with age, but older participants were more likely to fall behind expected reading levels compared with US norms. A 1-year increase in age was associated with a 19% increase in the likelihood for being below the expected WRAT word reading score (OR 1.19; 95% CI 1.06–1.33, p = 0.003). No associations were found between race and literacy. Wide variations in literacy were noted across age groups. All participants were able to complete the Pediatric PRO-CTCAE, although most 7 year olds (63%) required reading assistance. Those with lower literacy skills were able to understand items suggesting that multiple factors may be involved in comprehension (developmental stage, concentration, vocabulary, or prior health experiences). Risk for falling below expected literacy levels increased with age implying a need for literacy consideration for cancer patients.
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Cognitive Interview based validation of the patient reported outcomes version of the common terminology criteria for adverse events in adolescents with cancer
Journal of Pain and Symptom Management, 2017Co-Authors: Bryce B Reeve, Molly Mcfatrich, Laura C Pinheiro, Janice S Withycombe, Justin N. Baker, Lillian Sung, Jennifer W Mack, David R Freyer, Ethan Basch, Mia K WaldronAbstract:Abstract Context The National Cancer Institute created the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to allow direct input on symptomatic adverse events (AEs) from adult patients in oncology trials. Objectives This study sought to determine the youngest age to complete the PRO-CTCAE, evaluated comprehension of PRO-CTCAE among adolescents, tested new items not currently in PRO-CTCAE, and tested a parent-proxy version. Methods From seven pediatric cancer hospitals, 51 adolescents (13–20 years) receiving cancer treatment participated, along with 40 parent proxies. We evaluated 55 AEs from the PRO-CTCAE library (97 questions) and seven new AEs not in PRO-CTCAE that assess symptom frequency, severity, interference, or presence. Questions were distributed across three forms to reduce burden. Cognitive Interviews with retrospective probing were completed in age groups of 13–15 and 16–20 year olds. Proxies were Interviewed independently. Results In general, the 16–20 year olds and the parent proxies were able to understand and complete the PRO-CTCAE and newly designed AE questions. Five PRO-CTCAE terms (bloating of the abdomen, anxiety, flashing lights in front of your eyes, hot flashes, and bed sores) and the wording of the questions about AE severity were challenging for a few adolescents and proxies. The 13–15 year olds had greater challenges completing the PRO-CTCAE. Conclusion This study extends use of the adult PRO-CTCAE for adolescents as young as 16 years and proposes new questions for seven new symptomatic AEs and a parent-proxy version of PRO-CTCAE. Additional testing of the new questions and alternative language for more challenging PRO-CTCAE items is recommended in adults.
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eliciting the child s voice in adverse event reporting in oncology trials Cognitive Interview findings from the pediatric patient reported outcomes version of the common terminology criteria for adverse events initiative
Pediatric Blood & Cancer, 2017Co-Authors: Bryce B Reeve, Molly Mcfatrich, Laura C Pinheiro, Janice S Withycombe, Mia K Waldron, Meaghann S Weaver, Justin N. Baker, Lillian Sung, Jennifer W Mack, Deborah V GibsonAbstract:Background Adverse event (AE) reporting in oncology trials is required, but current practice does not directly integrate the child's voice. The Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being developed to assess symptomatic AEs via child/adolescent self-report or proxy-report. This qualitative study evaluates the child's/adolescent's understanding and ability to provide valid responses to the PRO-CTCAE to inform questionnaire refinements and confirm content validity. Procedure From seven pediatric research hospitals, children/adolescents ages 7–15 years who were diagnosed with cancer and receiving treatment were eligible, along with their parent-proxies. The Pediatric PRO-CTCAE includes 130 questions that assess 62 symptomatic AEs capturing symptom frequency, severity, interference, or presence. Cognitive Interviews with retrospective probing were completed with children in the age groups of 7–8, 9–12, and 13–15 years. The children/adolescents and proxies were Interviewed independently. Results Two rounds of Interviews involved 81 children and adolescents and 74 parent-proxies. Fifteen of the 62 AE terms were revised after Round 1, including refinements to the questions assessing symptom severity. Most participants rated the PRO-CTCAE AE items as “very easy” or “somewhat easy” and were able to read, understand, and provide valid responses to questions. A few AE items assessing rare events were challenging to understand. Conclusions The Pediatric and Proxy PRO-CTCAE performed well among children and adolescents and their proxies, supporting its content validity. Data from PRO-CTCAE may improve symptomatic AE reporting in clinical trials and enhance the quality of care that children receive.
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eliciting the child s voice in adverse event reporting in oncology trials Cognitive Interview findings from the pediatric patient reported outcomes version of the common terminology criteria for adverse events initiative
Pediatric Blood & Cancer, 2017Co-Authors: Bryce B Reeve, Molly Mcfatrich, Laura C Pinheiro, Janice S Withycombe, Mia K Waldron, Meaghann S Weaver, Justin N. Baker, Lillian Sung, Jennifer W Mack, Deborah V GibsonAbstract:Background Adverse event (AE) reporting in oncology trials is required, but current practice does not directly integrate the child's voice. The Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being developed to assess symptomatic AEs via child/adolescent self-report or proxy-report. This qualitative study evaluates the child's/adolescent's understanding and ability to provide valid responses to the PRO-CTCAE to inform questionnaire refinements and confirm content validity. Procedure From seven pediatric research hospitals, children/adolescents ages 7–15 years who were diagnosed with cancer and receiving treatment were eligible, along with their parent-proxies. The Pediatric PRO-CTCAE includes 130 questions that assess 62 symptomatic AEs capturing symptom frequency, severity, interference, or presence. Cognitive Interviews with retrospective probing were completed with children in the age groups of 7–8, 9–12, and 13–15 years. The children/adolescents and proxies were Interviewed independently. Results Two rounds of Interviews involved 81 children and adolescents and 74 parent-proxies. Fifteen of the 62 AE terms were revised after Round 1, including refinements to the questions assessing symptom severity. Most participants rated the PRO-CTCAE AE items as “very easy” or “somewhat easy” and were able to read, understand, and provide valid responses to questions. A few AE items assessing rare events were challenging to understand. Conclusions The Pediatric and Proxy PRO-CTCAE performed well among children and adolescents and their proxies, supporting its content validity. Data from PRO-CTCAE may improve symptomatic AE reporting in clinical trials and enhance the quality of care that children receive.
Justin N. Baker - One of the best experts on this subject based on the ideXlab platform.
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the association of age literacy and race on completing patient reported outcome measures in pediatric oncology
Quality of Life Research, 2019Co-Authors: Janice S Withycombe, Molly Mcfatrich, Laura C Pinheiro, Mia K Waldron, Justin N. Baker, Lillian Sung, Pamela S. Hinds, Frank G Keller, Jenny W Mack, Bryce B ReeveAbstract:Age is often used to determine when children can begin completing patient-reported outcome (PRO) instruments or transition to adult instruments. This study’s purpose was to determine relationships between literacy, age, and race and their influence on a child’s ability to understand and complete a PRO instrument. The Wide Range Achievement Test was used to evaluate literacy in children and young adults with cancer, participating in a Cognitive Interview for the Pediatric PRO-CTCAE instrument. 140 participants (7–20 years) were recruited from 8 sites. Logistic regression and multivariable liner regression were used to examine relationships among key variables. Higher literacy scores were significantly associated with fewer PRO-CTCAE items being identified as “hard to understand” (p = 0.017). Literacy scores increased with age, but older participants were more likely to fall behind expected reading levels compared with US norms. A 1-year increase in age was associated with a 19% increase in the likelihood for being below the expected WRAT word reading score (OR 1.19; 95% CI 1.06–1.33, p = 0.003). No associations were found between race and literacy. Wide variations in literacy were noted across age groups. All participants were able to complete the Pediatric PRO-CTCAE, although most 7 year olds (63%) required reading assistance. Those with lower literacy skills were able to understand items suggesting that multiple factors may be involved in comprehension (developmental stage, concentration, vocabulary, or prior health experiences). Risk for falling below expected literacy levels increased with age implying a need for literacy consideration for cancer patients.
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Cognitive Interview based validation of the patient reported outcomes version of the common terminology criteria for adverse events in adolescents with cancer
Journal of Pain and Symptom Management, 2017Co-Authors: Bryce B Reeve, Molly Mcfatrich, Laura C Pinheiro, Janice S Withycombe, Justin N. Baker, Lillian Sung, Jennifer W Mack, David R Freyer, Ethan Basch, Mia K WaldronAbstract:Abstract Context The National Cancer Institute created the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to allow direct input on symptomatic adverse events (AEs) from adult patients in oncology trials. Objectives This study sought to determine the youngest age to complete the PRO-CTCAE, evaluated comprehension of PRO-CTCAE among adolescents, tested new items not currently in PRO-CTCAE, and tested a parent-proxy version. Methods From seven pediatric cancer hospitals, 51 adolescents (13–20 years) receiving cancer treatment participated, along with 40 parent proxies. We evaluated 55 AEs from the PRO-CTCAE library (97 questions) and seven new AEs not in PRO-CTCAE that assess symptom frequency, severity, interference, or presence. Questions were distributed across three forms to reduce burden. Cognitive Interviews with retrospective probing were completed in age groups of 13–15 and 16–20 year olds. Proxies were Interviewed independently. Results In general, the 16–20 year olds and the parent proxies were able to understand and complete the PRO-CTCAE and newly designed AE questions. Five PRO-CTCAE terms (bloating of the abdomen, anxiety, flashing lights in front of your eyes, hot flashes, and bed sores) and the wording of the questions about AE severity were challenging for a few adolescents and proxies. The 13–15 year olds had greater challenges completing the PRO-CTCAE. Conclusion This study extends use of the adult PRO-CTCAE for adolescents as young as 16 years and proposes new questions for seven new symptomatic AEs and a parent-proxy version of PRO-CTCAE. Additional testing of the new questions and alternative language for more challenging PRO-CTCAE items is recommended in adults.
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eliciting the child s voice in adverse event reporting in oncology trials Cognitive Interview findings from the pediatric patient reported outcomes version of the common terminology criteria for adverse events initiative
Pediatric Blood & Cancer, 2017Co-Authors: Bryce B Reeve, Molly Mcfatrich, Laura C Pinheiro, Janice S Withycombe, Mia K Waldron, Meaghann S Weaver, Justin N. Baker, Lillian Sung, Jennifer W Mack, Deborah V GibsonAbstract:Background Adverse event (AE) reporting in oncology trials is required, but current practice does not directly integrate the child's voice. The Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being developed to assess symptomatic AEs via child/adolescent self-report or proxy-report. This qualitative study evaluates the child's/adolescent's understanding and ability to provide valid responses to the PRO-CTCAE to inform questionnaire refinements and confirm content validity. Procedure From seven pediatric research hospitals, children/adolescents ages 7–15 years who were diagnosed with cancer and receiving treatment were eligible, along with their parent-proxies. The Pediatric PRO-CTCAE includes 130 questions that assess 62 symptomatic AEs capturing symptom frequency, severity, interference, or presence. Cognitive Interviews with retrospective probing were completed with children in the age groups of 7–8, 9–12, and 13–15 years. The children/adolescents and proxies were Interviewed independently. Results Two rounds of Interviews involved 81 children and adolescents and 74 parent-proxies. Fifteen of the 62 AE terms were revised after Round 1, including refinements to the questions assessing symptom severity. Most participants rated the PRO-CTCAE AE items as “very easy” or “somewhat easy” and were able to read, understand, and provide valid responses to questions. A few AE items assessing rare events were challenging to understand. Conclusions The Pediatric and Proxy PRO-CTCAE performed well among children and adolescents and their proxies, supporting its content validity. Data from PRO-CTCAE may improve symptomatic AE reporting in clinical trials and enhance the quality of care that children receive.
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eliciting the child s voice in adverse event reporting in oncology trials Cognitive Interview findings from the pediatric patient reported outcomes version of the common terminology criteria for adverse events initiative
Pediatric Blood & Cancer, 2017Co-Authors: Bryce B Reeve, Molly Mcfatrich, Laura C Pinheiro, Janice S Withycombe, Mia K Waldron, Meaghann S Weaver, Justin N. Baker, Lillian Sung, Jennifer W Mack, Deborah V GibsonAbstract:Background Adverse event (AE) reporting in oncology trials is required, but current practice does not directly integrate the child's voice. The Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being developed to assess symptomatic AEs via child/adolescent self-report or proxy-report. This qualitative study evaluates the child's/adolescent's understanding and ability to provide valid responses to the PRO-CTCAE to inform questionnaire refinements and confirm content validity. Procedure From seven pediatric research hospitals, children/adolescents ages 7–15 years who were diagnosed with cancer and receiving treatment were eligible, along with their parent-proxies. The Pediatric PRO-CTCAE includes 130 questions that assess 62 symptomatic AEs capturing symptom frequency, severity, interference, or presence. Cognitive Interviews with retrospective probing were completed with children in the age groups of 7–8, 9–12, and 13–15 years. The children/adolescents and proxies were Interviewed independently. Results Two rounds of Interviews involved 81 children and adolescents and 74 parent-proxies. Fifteen of the 62 AE terms were revised after Round 1, including refinements to the questions assessing symptom severity. Most participants rated the PRO-CTCAE AE items as “very easy” or “somewhat easy” and were able to read, understand, and provide valid responses to questions. A few AE items assessing rare events were challenging to understand. Conclusions The Pediatric and Proxy PRO-CTCAE performed well among children and adolescents and their proxies, supporting its content validity. Data from PRO-CTCAE may improve symptomatic AE reporting in clinical trials and enhance the quality of care that children receive.
Lillian Sung - One of the best experts on this subject based on the ideXlab platform.
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the association of age literacy and race on completing patient reported outcome measures in pediatric oncology
Quality of Life Research, 2019Co-Authors: Janice S Withycombe, Molly Mcfatrich, Laura C Pinheiro, Mia K Waldron, Justin N. Baker, Lillian Sung, Pamela S. Hinds, Frank G Keller, Jenny W Mack, Bryce B ReeveAbstract:Age is often used to determine when children can begin completing patient-reported outcome (PRO) instruments or transition to adult instruments. This study’s purpose was to determine relationships between literacy, age, and race and their influence on a child’s ability to understand and complete a PRO instrument. The Wide Range Achievement Test was used to evaluate literacy in children and young adults with cancer, participating in a Cognitive Interview for the Pediatric PRO-CTCAE instrument. 140 participants (7–20 years) were recruited from 8 sites. Logistic regression and multivariable liner regression were used to examine relationships among key variables. Higher literacy scores were significantly associated with fewer PRO-CTCAE items being identified as “hard to understand” (p = 0.017). Literacy scores increased with age, but older participants were more likely to fall behind expected reading levels compared with US norms. A 1-year increase in age was associated with a 19% increase in the likelihood for being below the expected WRAT word reading score (OR 1.19; 95% CI 1.06–1.33, p = 0.003). No associations were found between race and literacy. Wide variations in literacy were noted across age groups. All participants were able to complete the Pediatric PRO-CTCAE, although most 7 year olds (63%) required reading assistance. Those with lower literacy skills were able to understand items suggesting that multiple factors may be involved in comprehension (developmental stage, concentration, vocabulary, or prior health experiences). Risk for falling below expected literacy levels increased with age implying a need for literacy consideration for cancer patients.
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Cognitive Interview based validation of the patient reported outcomes version of the common terminology criteria for adverse events in adolescents with cancer
Journal of Pain and Symptom Management, 2017Co-Authors: Bryce B Reeve, Molly Mcfatrich, Laura C Pinheiro, Janice S Withycombe, Justin N. Baker, Lillian Sung, Jennifer W Mack, David R Freyer, Ethan Basch, Mia K WaldronAbstract:Abstract Context The National Cancer Institute created the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to allow direct input on symptomatic adverse events (AEs) from adult patients in oncology trials. Objectives This study sought to determine the youngest age to complete the PRO-CTCAE, evaluated comprehension of PRO-CTCAE among adolescents, tested new items not currently in PRO-CTCAE, and tested a parent-proxy version. Methods From seven pediatric cancer hospitals, 51 adolescents (13–20 years) receiving cancer treatment participated, along with 40 parent proxies. We evaluated 55 AEs from the PRO-CTCAE library (97 questions) and seven new AEs not in PRO-CTCAE that assess symptom frequency, severity, interference, or presence. Questions were distributed across three forms to reduce burden. Cognitive Interviews with retrospective probing were completed in age groups of 13–15 and 16–20 year olds. Proxies were Interviewed independently. Results In general, the 16–20 year olds and the parent proxies were able to understand and complete the PRO-CTCAE and newly designed AE questions. Five PRO-CTCAE terms (bloating of the abdomen, anxiety, flashing lights in front of your eyes, hot flashes, and bed sores) and the wording of the questions about AE severity were challenging for a few adolescents and proxies. The 13–15 year olds had greater challenges completing the PRO-CTCAE. Conclusion This study extends use of the adult PRO-CTCAE for adolescents as young as 16 years and proposes new questions for seven new symptomatic AEs and a parent-proxy version of PRO-CTCAE. Additional testing of the new questions and alternative language for more challenging PRO-CTCAE items is recommended in adults.
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eliciting the child s voice in adverse event reporting in oncology trials Cognitive Interview findings from the pediatric patient reported outcomes version of the common terminology criteria for adverse events initiative
Pediatric Blood & Cancer, 2017Co-Authors: Bryce B Reeve, Molly Mcfatrich, Laura C Pinheiro, Janice S Withycombe, Mia K Waldron, Meaghann S Weaver, Justin N. Baker, Lillian Sung, Jennifer W Mack, Deborah V GibsonAbstract:Background Adverse event (AE) reporting in oncology trials is required, but current practice does not directly integrate the child's voice. The Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being developed to assess symptomatic AEs via child/adolescent self-report or proxy-report. This qualitative study evaluates the child's/adolescent's understanding and ability to provide valid responses to the PRO-CTCAE to inform questionnaire refinements and confirm content validity. Procedure From seven pediatric research hospitals, children/adolescents ages 7–15 years who were diagnosed with cancer and receiving treatment were eligible, along with their parent-proxies. The Pediatric PRO-CTCAE includes 130 questions that assess 62 symptomatic AEs capturing symptom frequency, severity, interference, or presence. Cognitive Interviews with retrospective probing were completed with children in the age groups of 7–8, 9–12, and 13–15 years. The children/adolescents and proxies were Interviewed independently. Results Two rounds of Interviews involved 81 children and adolescents and 74 parent-proxies. Fifteen of the 62 AE terms were revised after Round 1, including refinements to the questions assessing symptom severity. Most participants rated the PRO-CTCAE AE items as “very easy” or “somewhat easy” and were able to read, understand, and provide valid responses to questions. A few AE items assessing rare events were challenging to understand. Conclusions The Pediatric and Proxy PRO-CTCAE performed well among children and adolescents and their proxies, supporting its content validity. Data from PRO-CTCAE may improve symptomatic AE reporting in clinical trials and enhance the quality of care that children receive.
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eliciting the child s voice in adverse event reporting in oncology trials Cognitive Interview findings from the pediatric patient reported outcomes version of the common terminology criteria for adverse events initiative
Pediatric Blood & Cancer, 2017Co-Authors: Bryce B Reeve, Molly Mcfatrich, Laura C Pinheiro, Janice S Withycombe, Mia K Waldron, Meaghann S Weaver, Justin N. Baker, Lillian Sung, Jennifer W Mack, Deborah V GibsonAbstract:Background Adverse event (AE) reporting in oncology trials is required, but current practice does not directly integrate the child's voice. The Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being developed to assess symptomatic AEs via child/adolescent self-report or proxy-report. This qualitative study evaluates the child's/adolescent's understanding and ability to provide valid responses to the PRO-CTCAE to inform questionnaire refinements and confirm content validity. Procedure From seven pediatric research hospitals, children/adolescents ages 7–15 years who were diagnosed with cancer and receiving treatment were eligible, along with their parent-proxies. The Pediatric PRO-CTCAE includes 130 questions that assess 62 symptomatic AEs capturing symptom frequency, severity, interference, or presence. Cognitive Interviews with retrospective probing were completed with children in the age groups of 7–8, 9–12, and 13–15 years. The children/adolescents and proxies were Interviewed independently. Results Two rounds of Interviews involved 81 children and adolescents and 74 parent-proxies. Fifteen of the 62 AE terms were revised after Round 1, including refinements to the questions assessing symptom severity. Most participants rated the PRO-CTCAE AE items as “very easy” or “somewhat easy” and were able to read, understand, and provide valid responses to questions. A few AE items assessing rare events were challenging to understand. Conclusions The Pediatric and Proxy PRO-CTCAE performed well among children and adolescents and their proxies, supporting its content validity. Data from PRO-CTCAE may improve symptomatic AE reporting in clinical trials and enhance the quality of care that children receive.