Journal Article

Measuring what matters MOST: validation of the Measure of Ovarian Symptoms and Treatment, a patient-reported outcome measure of symptom burden and impact of chemotherapy in recurrent ovarian cancer

Oza, Amit, Avall-Lundqvist, Elisabeth, Lanceley, Anne, Aotani, Eriko, Donnellan, Paul, Sehouli, Jalid, Costa, Daniel S. J., Okamoto, Aikou, Bryce, Jane, Buizen, Luke, Joly, Florence, Berek, Jonathan S., Feeney, Amanda, King, Madeleine T., Berton-Rigaud, Dominique, Friedlander, Michael L., Hilpert, Felix, O'Connell, Rachel L., Stockler, Martin R.

2018

Overview

Purpose Gynecologic Cancer Intergroup Symptom Benefit Study (GCIG-SBS) Stage 2 aimed to review, revise, and validate a patient-reported outcome measure (PROM), the Measure of Ovarian Symptoms and Treatment concerns (MOST), developed in GCIG-SBS Stage 1 (MOSTv1, 35 items), and document recurrent ovarian cancer (ROC) symptom burden and benefit. Methods GCIG-SBS Stage 2 recruited patients with platinum-resistant/refractory ROC (PRR-ROC) or potentially platinum-sensitive ROC with ≥ 3 lines of prior chemotherapy (PPS-ROC ≥ 3). Patients completed MOSTv1, QLQ-C30, QLQ-OV28, and FACT-O/FOSI at baseline and before cycle 3 of chemotherapy (pre-C3), and global assessments of change (MOST-Change) pre-C3. Clinicians rated patients' cancer-related symptoms, performance status, and adverse events. Convergent and divergent validity (Spearman's correlations), discriminative validity (effect sizes between groups classified by clinicianrated characteristics), and responsiveness (paired t tests in patients expected to experience clinically meaningful change) were assessed. Results Of 948 recruits, 903 completed PROMs at baseline and 685 pre-C3. Baseline symptom burden was substantial for PRR-ROC and PPS-ROC ≥ 3. MOSTv2 has 24 items and five multi-item scales: abdominal symptoms (MOST-Abdo), disease or treatment-related symptoms (MOST-DorT), chemotherapy-related symptoms (MOST-Chemo), psychological symptoms (MOST-Psych), and MOST-Well-being. Correlations confirmed concurrent and divergent validity. Discriminative validity was confirmed by effect sizes that conformed with a priori hypotheses. MOST-Abdo was responsive to improvements in abdominal symptoms and MOST-Chemo detected the adverse effects of chemotherapy. Conclusions The MOSTv2 validly quantifies patient-reported symptom burden, adverse effects, and symptom benefit in ROC, and as such is fit-for-purpose for clinical trials of palliative chemotherapy in ROC. Further research is required to assess test-retest reliability.

• Publisher: Springer,Springer Science and Business Media LLC,Springer International Publishing,Springer Nature B.V
• Subject: Adult / Aged / Aged, 80 and over / Chemotherapy / Clinical outcomes / Cohort Studies / Female / Humans / Medicine / Medicine & Public Health / Middle Aged / Neoplasm Recurrence, Local / Neoplasm Recurrence, Local - pathology / Ovarian cancer / Ovarian Neoplasms / Ovarian Neoplasms - drug therapy / Ovarian Neoplasms - epidemiology / Ovarian Neoplasms - pathology / Patient Reported Outcome Measures / Patients / Prospective Studies / Public Health / Quality of Life / Quality of Life - psychology / Quality of Life Research / Reproducibility of Results / Side effects / Sociology / SPECIAL SECTION: MEASURING WHAT MATTERS / Special Section: Measuring What Matters (by invitation only) / Surveys and Questionnaires / Validity / Well being / Young Adult