Validating an Instrument for Direct Patient Reporting of Distress and Chemotherapy-Related Toxicity among South African Cancer Patients

Charmaine L Blanchard; Keletso Mmoledi; Michael H Antoni; Georgia Demetriou; Maureen Joffe; Gilberto Lopes; Paul Ruff; Daniel S O'Neil

doi:10.3390/cancers14010095

Validating an Instrument for Direct Patient Reporting of Distress and Chemotherapy-Related Toxicity among South African Cancer Patients

Cancers (Basel). 2021 Dec 24;14(1):95. doi: 10.3390/cancers14010095.

Authors

Charmaine L Blanchard^{1

2}, Keletso Mmoledi², Michael H Antoni^{3

4}, Georgia Demetriou⁵, Maureen Joffe^{2

6}, Gilberto Lopes³, Paul Ruff^{2

5}, Daniel S O'Neil³

Affiliations

¹ Centre for Palliative Care, Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2193, South Africa.
² Non-Communicable Disease Research Division, Wits Health Consortium (PTY) Ltd., Johannesburg 2193, South Africa.
³ Sylvester Comprehensive Cancer Center, University of Miami Health System, Miami, FL 33136, USA.
⁴ Department of Psychology, University of Miami, Miami, FL 33136, USA.
⁵ Division of Medical Oncology, Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg 2193, South Africa.
⁶ MRC Developmental Pathways to Health Research Unit, Department of Pediatrics, Faculty of Health Sciences, University of Witwatersrand, Johannesburg 2193, South Africa.

Abstract

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 p = 0.03). All but cough showed responsiveness to change in QLQ-C30 score (highest p = 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.

Keywords: South Africa; chemotherapy toxicity; distress; patient reported outcomes; quality of life.

Abstract

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