Translation Into Simplified Chinese and Cultural Validation of the Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Using Cognitive Interviewing

Shen, Nanping; Ruan, Haishan; Sun, Jiwen; Li, Yihan; He, Mengxue; Yuan, Changrong; Chang, Lilu

doi:10.1097/ncc.0000000000001090

Cited by 3 publications

(4 citation statements)

References 25 publications

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“…However, there were 3 concepts that were challenging for pediatric patients—peripheral neuropathy, anxiety, and difficulty sleeping. Patients who completed the Italian and Chinese translation cognitive interviews understood these concepts, but had more difficulty with dry eyes and throat [ 17 , 23 ]. Swahili is a Bantu language, influenced by Arabic and to a lesser extent, European language.…”

Section: Discussionmentioning

confidence: 99%

“…The translation of survey instruments for health research is a complex process involving both the language translation as well as cognitive testing to ensure phrasing is adapted to appropriately convey concepts that are specific to a particular region, country or population. Translation and linguistic validation of the adult PRO-CTCAE have been successfully completed in several languages, and the Ped-PRO-CTCAE has been translated for use among native speakers of Italian and Chinese (Simplified) [14][15][16][17]23].…”

Section: Introductionmentioning

confidence: 99%

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Swahili translation and cultural adaptation of the pediatric patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE)

Schroeder

Rizzieri²,

Lion

et al. 2023

J Patient Rep Outcomes

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Background The pediatric patient-reported outcomes version of the common terminology criteria for adverse event measure was developed and validated for use in pediatric cancer clinical trials to better capture the symptom experiences through direct self-report. The study aim was to develop and validate a Swahili language version of the patient-reported outcomes version of the common terminology criteria for adverse event measure. Methods The pediatric version of 15 core symptom adverse events, and the corresponding questions, were selected from the patient-reported outcomes version of the common terminology criteria for adverse event library, then forward and back translated into Swahili by bilingual translators. The translated items were further refined using concurrent cognitive interviewing. Each round of interviews included five children, ages 8–17 years-old, receiving cancer therapy at Bugando Medical Centre, the cancer referral hospital for Northwest Tanzania, and continued until at least 80% of participants understood the question. Results Three rounds of cognitive interviews were completed involving 13 patients and 5 caregivers. Among patients, 50% of questions (19/38) were fully comprehended after the first interview round. Two Adverse Events (anxiety and peripheral neuropathy) were the most difficult for participants to understand, associated with education level and experience. Goal comprehension was achieved after three rounds of interviews with no further revisions required. All parents in the first cognitive interview group comprehended the survey, with no additional revisions. Conclusion A Swahili patient-reported outcomes version of the common terminology criteria for adverse event was effective in eliciting patient-reported Adverse Events related to cancer treatment, with good comprehension for children aged 8–17 years. This survey is important to incorporate patient self-reporting of symptomatic toxicities and is an effective tool to increase capacity for pediatric cancer clinical trials throughout East Africa, further reducing global disparities in cancer care.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Swahili translation and cultural adaptation of the pediatric patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE)

Schroeder

Rizzieri²,

Lion

et al. 2023

J Patient Rep Outcomes

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show abstract

“…The Ped-PRO-CTCAE is a newly available and reliable measurement tool used to assess subjective AEs in children aged 7 to 18 years diagnosed with cancer. The Ped-PRO-CTCAE comprises 130 questions representing 62 subjective AEs; of these, the 15 most frequently occurring AE items are considered “core subjective terms” across various cancer types 20,24 . For each AE item, up to 3 questions were created to reflect the attributes of symptom frequency, severity, and interference with daily activities.…”

Section: Methodsmentioning

confidence: 99%

“…The Ped-PRO-CTCAE comprises 130 questions representing 62 subjective AEs; of these, the 15 most frequently occurring AE items are considered "core subjective terms" across various cancer types. 20,24 For each AE item, up to 3 questions were created to reflect the attributes of symptom frequency, severity, and interference with daily activities. The attribute scores ranged from 0 to 3.…”

Section: Chinese Version Of the Ped-pro-ctcaementioning

confidence: 99%

Subjective Toxicity Profiles of Children With Cancer During Treatment

et al. 2023

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Background: Children and adolescents may experience a variety of subjective adverse events (AEs) caused by cancer treatment. The identification of distinct groups of patients is crucial for guiding symptomatic AE management interventions to prevent AEs from worsening. Objective: The aim of this study was to identify subgroups of children with cancer experiencing similar patterns of subjective toxicities and evaluate differences among these subgroups in demographic and clinical characteristics. Methods: A cross-sectional survey was conducted of 356 children in China with malignancies who received chemotherapy within the past 7 days using the pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. A latent class analysis (LCA) was conducted to identify subgroups of patients with distinct profiles of symptomatic AE occurrence. Results: Nausea (54.5%), anorexia (53.4%), and headache (39.3%) were the top 3 AEs children experienced. Nearly all participants (97. 8%) experienced ≥1 core AEs, and 30.3% experienced ≥5 AEs. The LCA results identified 3 subgroups ("high gastrotoxicity and low neurotoxicity" [53.2%], "moderate gastrotoxicity and high neurotoxicity" [23.6%], and "high gastrotoxicity and high neurotoxicity" [22.8%]). The subgroups were differentiated by monthly family per-capita income, time since diagnosis, and Karnofsky Performance Status score. Conclusions: Children experienced multiple subjective toxicities during chemotherapy, especially gastrotoxicity and neurotoxicity. Heterogeneity was found in the LCA in the patients'

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A Predictive Model of Severe Cytokine Release Syndrome After Coadministration of CD19- and CD22-Chimeric Antigen Receptor T-Cell Therapy in Children With B-Cell Hematological Malignancies Based on Patient-Reported Outcomes

Zhao

Sun

et al. 2023

Cancer Nurs

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Background Chimeric antigen receptor T-cell therapy–related severe cytokine release syndrome (sCRS) has seriously affected the life safety of patients. Objective To explore the influencing factors of sCRS in children with B-cell hematological malignancies and build a risk prediction model. Methods The study recruited 115 children with B-cell hematological malignancies who received CD19- and CD22-targeted chimeric antigen receptor T-cell therapy. A nomogram model was established based on symptomatic adverse events and highly accessible clinical variables. The model discrimination was evaluated by the area under the receiver operating characteristic curve. The calibration of our model was evaluated by the calibration curve and Hosmer-Lemeshow test. The bootstrap self-sampling method was used to internally validate. Results Thirty-seven percent of the children experienced sCRS. Indicators included in the nomogram were tumor burden before treatment, thrombocytopenia before pretreatment, and the mean value of generalized muscle weakness and headache scores. The results showed that the area under the receiver operating characteristic curve was 0.841, and the calibration curve showed that the probability of sCRS predicted by the nomogram was in good agreement with the actual probability of sCRS. The Hosmer-Lemeshow test indicated that the model fit the data well (χ 2 = 5.759, P = .674). The concordance index (C-index) obtained by internal validation was 0.841 (0.770, 0.912). Conclusions The nomogram model constructed has a good degree of discrimination and calibration, which provides a more convenient and visual evaluation tool for identifying the sCRS. Implications for Practice Incorporation of patient-reported outcomes into risk prediction models enables early identification of sCRS.

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Translation Into Simplified Chinese and Cultural Validation of the Pediatric Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events Using Cognitive Interviewing

Cited by 3 publications

References 25 publications

Swahili translation and cultural adaptation of the pediatric patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE)

Swahili translation and cultural adaptation of the pediatric patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE)

Subjective Toxicity Profiles of Children With Cancer During Treatment

A Predictive Model of Severe Cytokine Release Syndrome After Coadministration of CD19- and CD22-Chimeric Antigen Receptor T-Cell Therapy in Children With B-Cell Hematological Malignancies Based on Patient-Reported Outcomes

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