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

被引：41

作者：

King, Madeleine T. ^{[1
,2
,3
]}

Stockler, Martin R. ^{[3
,4
]}

O'Connell, Rachel L. ^{[4
]}

Buizen, Luke ^{[4
]}

Joly, Florence ^{[5
,6
]}

Lanceley, Anne ^{[7
]}

Hilpert, Felix ^{[8
,9
]}

Okamoto, Aikou ^{[10
,11
]}

Aotani, Eriko ^{[12
,13
]}

Bryce, Jane ^{[14
,15
]}

Donnellan, Paul ^{[16
]}

Oza, Amit ^{[17
,18
]}

Avall-Lundqvist, Elisabeth ^{[19
,20
,21
,22
]}

Berek, Jonathan S. ^{[23
,24
]}

Sehouli, Jalid ^{[9
,25
]}

Feeney, Amanda ^{[26
,27
]}

Berton-Rigaud, Dominique ^{[6
,28
]}

Costa, Daniel S. J. ^{[2
,29
]}

Friedlander, Michael L. ^{[3
,30
]}

机构：

[1] Univ Sydney, Fac Sci, Sch Psychol, Qual Life Off,Psychooncol Cooperat Res Grp, Level 6 North,Chris O Brien Lifehouse C39Z, Sydney, NSW 2006, Australia

[2] Univ Sydney, Fac Med, Sydney Med Sch, Sydney, NSW, Australia

[3] Australia New Zealand Gynaecol Oncol ANZGOG, Camperdown, NSW, Australia

[4] Univ Sydney, Natl Hlth & Med Res Council NHMRC, Clin Trials Ctr, Sydney, NSW, Australia

[5] Ctr Francois Baclesse, Caen, France

[6] GINECO, Paris, France

[7] UCL, UCL Elizabeth Garrett Anderson Inst Womens Hlth, London, England

[8] Krankenhaus Jerusalem Hamburg, Onkol Therapiezentrum, Hamburg, Germany

[9] AGO Study Grp, Wiesbaden, Germany

[10] Jikei Univ, Sch Med, Tokyo, Japan

[11] JGOG, Tokyo, Japan

[12] Kanagawa Acad Sci & Technol, Global Hlth Res Coordinating Ctr, Kawasaki, Kanagawa, Japan

[13] GOTIC, Saitama, Japan

[14] IRCCS, Fdn G Pascale, Ist Nazl Tumori, Naples, Italy

[15] Multictr Italian Trials Ovarian Canc & Gynecol Ma, Naples, Italy

[16] Galway Univ Hosp, Canc Trials Ireland, Galway, Ireland

[17] Univ Toronto, Princess Margaret Canc Ctr, Toronto, ON, Canada

[18] Princess Margaret Consortium PMHC, Toronto, ON, Canada

[19] Linkoping Univ, NSGO, Dept Oncol, Linkoping, Sweden

[20] Linkoping Univ, NSGO, Dept Clin & Expt Med, Linkoping, Sweden

[21] Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden

[22] NSGO, Copenhagen, Denmark

[23] Stanford Comprehens Canc Inst, Stanford, CA USA

[24] Cooperat Ovarian Canc Grp COGi, Stanford, CA USA

[25] Univ Berlin, Dept Gynecol & Oncol Surg, Charite, Berlin, Germany

[26] UCL, Canc Res UK, London, England

[27] UCL, UCL Canc Trials Ctr, London, England

[28] Ctr Rene Gauducheau, ICO, St Herblain, France

[29] Royal North Shore Hosp, Pain Management Res Inst, St Leonards, NSW, Australia

[30] Univ New South Wales, Prince Wales Clin Sch, Sydney, NSW, Australia

[31] Gynecol Canc Intergrp GCIG, GCIG Symptom Benefit Study Grp, Kingston, ON, Canada

来源：

QUALITY OF LIFE RESEARCH | 2018年 / 27卷 / 01期

基金：

澳大利亚国家健康与医学研究理事会;

关键词：

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; QUALITY-OF-LIFE; CLINICAL-TRIALS; COMPOSITE INDICATORS; CAUSAL; RELIABILITY; VALIDITY; THERAPY;

D O I：

10.1007/s11136-017-1729-8

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

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 ae<yen> 3 lines of prior chemotherapy (PPS-ROC ae<yen> 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. Of 948 recruits, 903 completed PROMs at baseline and 685 pre-C3. Baseline symptom burden was substantial for PRR-ROC and PPS-ROC ae<yen> 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.

引用

页码：59 / 74

页数：16

共 31 条

[1] THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER QLQ-C30 - A QUALITY-OF-LIFE INSTRUMENT FOR USE IN INTERNATIONAL CLINICAL-TRIALS IN ONCOLOGY [J].