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.
Qual Life Res
; 27(1): 59-74, 2018 01.
Article
in En
| MEDLINE
| ID: mdl-29248998
ABSTRACT
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 clinician-rated 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.Key words
HRQL; HRQOL; Health-related quality of life; Magnitude of clinical benefit; Net health benefit; Ovarian cancer; PRO; PROM; Patient-reported outcome; Patient-reported outcome measure; Platinum refractory; Platinum resistant; Platinum sensitive; QOL; Quality of life; Recurrent ovarian cancer; Symptom benefit; Symptom burden
Full text:
1
Database:
MEDLINE
Main subject:
Ovarian Neoplasms
/
Quality of Life
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Patient Reported Outcome Measures
/
Neoplasm Recurrence, Local
Type of study:
Diagnostic_studies
/
Etiology_studies
/
Incidence_studies
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Observational_studies
/
Qualitative_research
/
Risk_factors_studies
Limits:
Adult
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Aged
/
Aged80
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Female
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Humans
/
Middle aged
Language:
En
Journal:
Qual Life Res
Journal subject:
REABILITACAO
/
TERAPEUTICA
Year:
2018
Type:
Article
Affiliation country:
Australia