Duke Medicine, Durham, NC, USA.
Bugando Medical Centre, Mwanza, Tanzania.
J Patient Rep Outcomes. 2023 Jun 12;7(1):56. doi: 10.1186/s41687-023-00598-4.
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.
背景：儿童患者报告结局版常见不良事件术语标准是为了在儿科癌症临床试验中更好地通过直接自我报告来捕捉症状体验而开发和验证的。本研究旨在开发和验证一种斯瓦希里语版的患者报告结局版常见不良事件术语标准。
方法：从患者报告结局版常见不良事件术语标准库中选择了 15 项核心症状不良事件及其对应的问题，然后由双语翻译人员将其正向和反向翻译为斯瓦希里语。翻译后的项目进一步使用同期认知访谈进行了细化。每一轮访谈包括五名年龄在 8-17 岁之间、正在布甘达医疗中心接受癌症治疗的儿童，该中心是坦桑尼亚西北部的癌症转诊医院，并且访谈持续进行，直到至少 80%的参与者理解了问题。
结果：共完成了三轮认知访谈，涉及 13 名患者和 5 名照顾者。在患者中，有 50%的问题（19/38）在第一轮访谈后完全理解。两个不良事件（焦虑和周围神经病）是参与者最难理解的，与教育程度和经验有关。在三轮访谈后，目标理解得以实现，无需进一步修订。第一组认知访谈的所有家长都理解了调查，无需进一步修订。
结论：一种斯瓦希里语版的患者报告结局版常见不良事件术语标准能够有效地引出与癌症治疗相关的患者报告的不良事件，并且 8-17 岁的儿童理解良好。该调查对于纳入患者对毒性症状的自我报告非常重要，是在东非增加儿科癌症临床试验能力、进一步减少全球癌症护理差距的有效工具。
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