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 cancerShow others and affiliations
2018 (English)In: Quality of Life Research, ISSN 0962-9343, E-ISSN 1573-2649, Vol. 27, no 1, p. 59-74Article in journal (Refereed) Published
Abstract [en]
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. GCIG-SBS Stage 2 recruited patients with platinum-resistant/refractory ROC (PRR-ROC) or potentially platinum-sensitive ROC with aeamp;lt;yenamp;gt; 3 lines of prior chemotherapy (PPS-ROC aeamp;lt;yenamp;gt; 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 (Spearmans correlations), discriminative validity (effect sizes between groups classified by clinician-rated characteristics), and responsiveness (paired t tests in patients expected to experience clinically meaningful change) were assessed. Of 948 recruits, 903 completed PROMs at baseline and 685 pre-C3. Baseline symptom burden was substantial for PRR-ROC and PPS-ROC aeamp;lt;yenamp;gt; 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. 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.
Place, publisher, year, edition, pages
SPRINGER , 2018. Vol. 27, no 1, p. 59-74
Keywords [en]
Ovarian cancer; Recurrent ovarian cancer; Platinum sensitive; Platinum resistant; Platinum refractory; Symptom burden; Symptom benefit; Magnitude of clinical benefit; Net health benefit; Patient-reported outcome; PRO; Patient-reported outcome measure; PROM; Quality of life; QOL; Health-related quality of life; HRQOL; HRQL
National Category
Neurology
Identifiers
URN: urn:nbn:se:liu:diva-144892DOI: 10.1007/s11136-017-1729-8ISI: 000422793600007PubMedID: 29248998OAI: oai:DiVA.org:liu-144892DiVA, id: diva2:1181666
Note
Funding Agencies|NHMRC [1063012, 570,893]; Target Ovarian Cancer [UCL-P001AL]; Cancer Research UK [C444/A15953]; UCL Cancer Trials Centre [C444/A15953]; Australian Government through Cancer Australia; NHMRC; Department of Health
2018-02-092018-02-092019-04-09