Blanchard Charmaine L, Mmoledi Keletso, Antoni Michael H, Demetriou Georgia, Joffe Maureen, Lopes Gilberto, Ruff Paul, O'Neil Daniel S
Centre for Palliative Care, Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2193, South Africa.
Non-Communicable Disease Research Division, Wits Health Consortium (PTY) Ltd., Johannesburg 2193, South Africa.
Cancers (Basel). 2021 Dec 24;14(1):95. doi: 10.3390/cancers14010095.
Patient-reported outcome measures (PROM) for monitoring treatment toxicity improve quality of life (QoL) and clinical outcomes. However, no such PROMs exist for sub-Saharan African cancer patients. We aimed to validate the Patient Reported Symptoms-South Africa (PRS-SA) survey, a novel PROM for measuring distress and chemotherapy-related symptoms in South African cancer patients. We enrolled patients at the oncology clinic at Charlotte Maxeke Hospital, Johannesburg. At three separate visits, participants simultaneously completed the PRS-SA survey and several previously validated questionnaires. We constructed a receiver operator characteristics curve for distress levels predicting a Hospital Anxiety and Depression Scale (HADS) score ≥15. We evaluated construct validity for symptom items by comparing severity to the EORTC Core Quality of Life Questionnaire (QLQ-C30) summary score (Pearson correlation tests) and ECOG performance status (Mann-Whitney U tests). We assessed symptom item responsiveness by comparing change in severity to change in QLQ-C30 summary score and comparing standardized mean scores with negative, no, or positive change on the Global Impression of Change (GIC) questionnaire (Jockheere-Terpstra trend test). Overall, 196 participants with solid tumors completed instruments. A distress score of 4 had 82% sensitivity and 55% specificity for clinical depression/anxiety. All symptom items showed construct validity by association with either QLQ-C30 score or performance status (highest = 0.03). All but cough showed responsiveness to change in QLQ-C30 score (highest = 0.045). In South African cancer patients, the PRS-SA's stress scale behaves similarly to the distress thermometer in other populations, and the symptom items demonstrated construct validity and responsiveness. Of note, 46% and 74% of participants who completed the PRS-SA in English or isiZulu, respectively, required assistance reading half or more of the instrument.
用于监测治疗毒性的患者报告结局指标（PROM）可改善生活质量（QoL）和临床结局。然而，撒哈拉以南非洲癌症患者尚无此类PROM。我们旨在验证患者报告症状-南非（PRS-SA）调查问卷，这是一种用于测量南非癌症患者痛苦和化疗相关症状的新型PROM。我们在约翰内斯堡夏洛特·马克西克医院的肿瘤诊所招募患者。在三次单独就诊时，参与者同时完成PRS-SA调查问卷和几份先前验证过的问卷。我们构建了预测医院焦虑抑郁量表（HADS）评分≥15的痛苦水平的受试者工作特征曲线。我们通过将严重程度与欧洲癌症研究与治疗组织核心生活质量问卷（QLQ-C30）总结评分（Pearson相关检验）和东部肿瘤协作组体能状态（Mann-Whitney U检验）进行比较，评估症状项目的结构效度。我们通过将严重程度变化与QLQ-C30总结评分变化进行比较，并将标准化平均评分与全球变化印象（GIC）问卷上的负向、无或正向变化进行比较（Jockheere-Terpstra趋势检验），评估症状项目的反应度。总体而言，196名实体瘤患者完成了相关测评。痛苦评分为4时，对临床抑郁/焦虑的敏感性为82%，特异性为55%。所有症状项目均通过与QLQ-C30评分或体能状态相关联显示出结构效度（最高为0.03）。除咳嗽外，所有症状项目均显示出对QLQ-C30评分变化的反应度（最高为0.045）。在南非癌症患者中，PRS-SA的压力量表在行为上与其他人群的痛苦温度计相似，症状项目显示出结构效度和反应度。值得注意的是，分别以英语或isiZulu完成PRS-SA的参与者中，有46%和74%在阅读该测评工具一半或更多内容时需要帮助。
