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3. Relationship between reasons for intermittent missing patient-reported outcomes data and missing data mechanisms

Author

Nielsen, Lene Kongsgaard, Mercieca-Bebber, Rebecca, Möller, Sören, Redder, Louise, Jarden, Mary, Andersen, Christen Lykkegaard, Frederiksen, Henrik, Svirskaite, Asta, Silkjær, Trine, Steffensen, Morten Saaby, Pedersen, Per Trøllund, Hinge, Maja, Frederiksen, Mikael, Jensen, Bo Amdi, Helleberg, Carsten, Mylin, Anne Kærsgaard, Abildgaard, Niels, and King, Madeleine T.

Published
2024
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8. Health-related quality of life and quality-adjusted progression free survival for carfilzomib and dexamethasone maintenance following salvage autologous stem-cell transplantation in patients with multiple myeloma: a randomized phase 2 trial by the Nordic Myeloma Study Group

Author

Nielsen, Lene Kongsgaard, Schjesvold, Fredrik, Möller, Sören, Guldbrandsen, Nina, Hansson, Markus, Remes, Kari, Peceliunas, Valdas, Abildgaard, Niels, Gregersen, Henrik, and King, Madeleine T.

Published
2024
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11. The FACT-8D, a new cancer-specific utility algorithm based on the Functional Assessment of Cancer Therapies-General (FACT-G): a Canadian valuation study

Author

McTaggart-Cowan, Helen, King, Madeleine T, Norman, Richard, Costa, Daniel SJ, Pickard, A Simon, Viney, Rosalie, and Peacock, Stuart J

Subjects
Chronic Pain, Pain Research, Clinical Research, Cancer, Good Health and Well Being, Algorithms, Canada, Health Status, Humans, Nausea, Neoplasms, Pain, Quality of Life, Quality-Adjusted Life Years, Surveys and Questionnaires, Discrete choice experiment, FACT-G, health-related quality of life, utility, Canadian MAUCa Team, FACT-G, health-related quality of life, utility, Public Health and Health Services, Health Policy & Services
Abstract

IntroductionUtility instruments are used to assess patients' health-related quality of life for cost-utility analysis (CUA). However, for cancer patients, the dimensions of generic utility instruments may not capture all the information relevant to the impact of cancer. Cancer-specific utilities provide a useful alternative. Under the auspices of the Multi-Attribute Utility in Cancer Consortium, a cancer-specific utility algorithm was derived from the FACT-G. The new FACT-8D contains eight dimensions: pain, fatigue, nausea, sleep, work, support from family/friends, sadness, and worry health will get worse. The aim of the study was to obtain a Canadian value set for the FACT-8D.MethodsA discrete choice experiment was administered to a Canadian general population online panel, quota sampled by age, sex, and province/territory of residence. Respondents provided responses to 16 choice sets. Each choice set consisted of two health states described by the FACT-8D dimensions plus an attribute representing survival duration. Sample weights were applied and the responses were analyzed using conditional logistic regression, parameterized to fit the quality-adjusted life year framework. The results were converted into utility weights by evaluating the marginal rate of substitution between each level of each FACT-8D dimension with respect to duration.Results2228 individuals were recruited. The analysis dataset included n = 1582 individuals, who completed at least one choice set; of which, n = 1501 completed all choice sets. After constraining to ensure monotonicity in the utility function, the largest decrements were for the highest levels of pain (- 0.38), nausea (- 0.30), and problems doing work (- 0.23). The decrements of the remaining dimensions ranged from - 0.08 to - 0.18 for their highest levels. The utility of the worst possible health state was defined as - 0.65, considerably worse than dead.ConclusionsThe largest impacts on utility included three generic dimensions (i.e., pain, support, and work) and nausea, a symptom caused by cancer (e.g., brain tumours, gastrointestinal tumours, malignant bowel obstruction) and by common treatments (e.g., chemotherapy, radiotherapy, opioid analgesics). This may make the FACT-8D more informative for CUA evaluating in many cancer contexts, an assertion that must now be tested empirically in head-to-head comparisons with generic utility measures.

Published
2022

14. Hidden in plain sight – Survival consequences of baseline symptom burden in women with recurrent ovarian cancer

Author

Roncolato, Felicia, King, Madeleine T., O'Connell, Rachel L., Lee, Yeh Chen, Joly, Florence, Hilpert, Felix, Lanceley, Anne, Yoshida, Yoshio, Bryce, Jane, Donnellan, Paul, Oza, Amit, Avall-Lundqvist, Elisabeth, Berek, Jonathan S., Ledermann, Jonathan A., Berton, Dominique, Sehouli, Jalid, Kaminsky, Marie-Christine, Stockler, Martin R., and Friedlander, Michael

Published
2024
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17. Minimally important differences for interpreting EORTC QLQ-C30 change scores over time: A synthesis across 21 clinical trials involving nine different cancer types

Author

Musoro, Jammbe Z., Coens, Corneel, Sprangers, Mirjam A.G., Brandberg, Yvonne, Groenvold, Mogens, Flechtner, Hans-Henning, Cocks, Kim, Velikova, Galina, Dirven, Linda, Greimel, Elfriede, Singer, Susanne, Pogoda, Katarzyna, Gamper, Eva M., Sodergren, Samantha C., Eggermont, Alexander, Koller, Michael, Reijneveld, Jaap C., Taphoorn, Martin J.B., King, Madeleine T., and Bottomley, Andrew

Published
2023
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19. Adjuvant chemotherapy following chemoradiotherapy as primary treatment for locally advanced cervical cancer versus chemoradiotherapy alone (OUTBACK): an international, open-label, randomised, phase 3 trial

Author

Mileshkin, Linda R, Moore, Kathleen N, Barnes, Elizabeth H, Gebski, Val, Narayan, Kailash, King, Madeleine T, Bradshaw, Nathan, Lee, Yeh Chen, Diamante, Katrina, Fyles, Anthony W, Small, William, Jr, Gaffney, David K, Khaw, Pearly, Brooks, Susan, Thompson, J Spencer, Huh, Warner K, Mathews, Cara A, Buck, Martin, Suder, Aneta, Lad, Thomas E, Barani, Igor J, Holschneider, Christine H, Van Dyk, Sylvia, Quinn, Michael, Rischin, Danny, Monk, Bradley J, and Stockler, Martin R

Published
2023
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24. Apples to apples? Comparison of the measurement properties of hospital anxiety and depression-anxiety subscale (HADS-A), depression, anxiety and stress scale-anxiety subscale (DASS-A), and generalised anxiety disorder (GAD-7) scale in an oncology setting using Rasch analysis and diagnostic accuracy statistics

Author

Clover, Kerrie, Lambert, Sylvie D., Oldmeadow, Christopher, Britton, Benjamin, King, Madeleine T., Mitchell, Alex J., and Carter, Gregory L.

Subjects
Cancer patients -- Psychological aspects, Anxiety -- Analysis -- Psychological aspects, Stress (Psychology) -- Analysis -- Psychological aspects, Psychology and mental health
Abstract

A range of anxiety measures is used in oncology but their comparability is unknown. We examined variations in measurement across three commonly used instruments: Hospital Anxiety and Depression-Anxiety subscale (HADS-A); Depression, Anxiety, Stress Scale - Anxiety subscale (DASS-A); and Generalised Anxiety Disorder scale (GAD-7). Participants (n = 164) completed the self-report measures and the Generalised Anxiety Disorder module of the Structured Clinical Interview for DSM-IV (SCID). We performed Rasch analysis and calculated diagnostic accuracy statistics. Instruments measured similar constructs of anxiety, but had different ranges of measurement, with the HADS-A including lower severity symptoms than the other two measures. Anxiety severity was similar for GAD-7 'mild' and HADS-A 'possible' categories, but 'mild' anxiety on the DASS-A represented more severe symptoms. Conversely, DASS-A 'severe' anxiety represented less intense symptoms than GAD-7 'severe' anxiety. Co-calibration indicated a score of eight on the HADS-A was equivalent in anxiety severity to scores of three on the DASS-A and six on the GAD-7. Area under the curve (AUC) was just acceptable for HADS-A and GAD-7 but not DASS-A. The HADS-A, DASS-A and GAD-7 displayed important differences in how they measured anxiety. In particular, categorical classifications of anxiety severity (mild/moderate/severe) were not equivalent across instruments. Thus, prevalence estimates of anxiety symptoms will vary as a consequence of the instrument used. The GAD-7 and HADS-A obtained more similar results and better AUC than the DASS-A. Our co-calibration could be used in future studies and meta-analyses of individual participant data to set cut-off points that provide more consistent classification of anxiety severity., Author(s): Kerrie Clover [sup.1] [sup.2] , Sylvie D. Lambert [sup.3] , Christopher Oldmeadow [sup.4] , Benjamin Britton [sup.2] , Madeleine T. King [sup.5] , Alex J. Mitchell [sup.6] , Gregory [...]

Published
2022
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33. The Functional Assessment of Cancer Therapy Eight Dimension (FACT-8D), a Multi-Attribute Utility Instrument Derived From the Cancer-Specific FACT-General (FACT-G) Quality of Life Questionnaire: Development and Australian Value Set

Author

Aaronson, N., Brazier, J., Cella, D., Costa, D.S.J., Fayers, P., Grimison, P., Janda, M., Kemmler, G., King, M.T., McTaggart-Cowan, H., Mercieca-Bebber, R., Norman, R., Peacock, S., Pickard, A.S., Rowen, D., Velikova, G., Viney, R., Street, D., Young, T., King, Madeleine T., Norman, Richard, Mercieca-Bebber, Rebecca, Costa, Daniel S.J., McTaggart-Cowan, Helen, Peacock, Stuart, Janda, Monika, Müller, Fabiola, Viney, Rosalie, Pickard, Alan Simon, and Cella, David

Published
2021
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36. Quality of life after breast-conserving therapy and adjuvant radiotherapy for non-low-risk ductal carcinoma in situ (BIG 3-07/TROG 07.01): 2-year results of a randomised, controlled, phase 3 trial

Author

Chua, Boon H, Phillips, Claire, Bryant, Guy, Westenberg, Helen, Purohit, Om Pra-Kesh, Ahern, Verity, Graham, Peter, Akra, Mohamed, McArdle, Orla, O'Brien, Peter, Ludbrook, Jane, Harvey, Jennifer, Maduro, John H, Gabelle-Flandin, Isabelle, Kirkove, Carine, Bedi, Carolyn, Martin, Joseph, Vu, Tony, Muanza, Theirry, Neal, Anthony, Courdi, Adel, Thariat, Juliette, Rakovitch, Eileen, Daniels, Laurien, van Hezewijk, Marjan, Cwajna, Wlasyslawa, Roelstraete, Adelheid, van Baardwijk, Angela, Russel, Nicola, Koch, Anne, Croke, Jennifer, Locke, Imogen, Jeal, Peter, Walker, Quenten, Thuraisingham, Kandeepeepan, Chauduri, Anupam, Joseph, David, Taylor, Mandy, Vanderkam, Sabine, Woo, Tony, Tang, Johann, Yassa, Michael, Wai, Elaine, Hewitt, Susan, Mahmood, Shazia, Gilmore, Jennifer, Ofi, Bolante, Bahl, Amit, Vujovic, Olga, Yu, Edward, Le, Duc, Kong, Iwa, Nichol, Alan, Bijker, Nina, Delaney, Geoff, Feigen, Malcolm, Lim, Adeline, Chao, Michael, Latham, Margaret, Algurafi, Hafiz, Tausch, Christoph, Khoo, Eric, Leung, Sam, Taylor, Karen, Senthi, Sasha, Stevens, Andrea, Chaudhuri, Abhro, Cleator, Susan, Brunt, Adrian Murray, Babington, Scott, Christie, David, Zwahlen, Daniel, Schratzenstaller, Ulrich, Masson, Laurence, Storey, Nicola, Kumar, Eshwar, Sherwin, Liz, Weytjens, Reinhilde, Ravi, Sharma, Lawton, Patricia, Angell, Ruth, Round, Glenys, Allen, Angela, Thotathil, Ziad, Anthes, Margaret, Reuter, Christiane, Pettit, Laura, Zissiadis, Yvonne, Elder, Christine, Verbeek-de Kanter, Antoinette, Lirette, Andree, Plasswilm, Ludwig, Spooner, David, Hoar, Fiona, Mohamed, Islam, Lossl, Kristina, Loo, Vivienne, Richetti, Antonella, Evans, Tamasin, Hennessy, Aisling, El-Mallah, Medhat, Skala, Marketa, Awad, Raef, Germain, Isabelle, Mitine, Carine, Van Parijs, Hilde, Churn, Mark, Walji, Nawaz, Francis, Michael, Stellamans, Karin, Gruber, Gunther, Ivaldi, Giovanni, Alhasso, Abdulla, Kenny, Lizbeth, Tiver, Ken, Griffin, Matthew, Lamoury, Gillian, Trovo, Marco, Algufarfi, Hafiz, Lah, Minjae, Carruthers, Scott, Papadatos, George, Paardekooper, Gabriel, Persic, Mojca, Lavery, Bernadette, King, Madeleine T, Link, Emma K, Whelan, Tim J, Olivotto, Ivo A, Kunkler, Ian, Westenberg, Antonia Helen, Gruber, Guenther, and Schofield, Penny

Published
2020
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37. Symptom burden and quality of life with chemotherapy for recurrent ovarian cancer: the Gynecologic Cancer InterGroup-Symptom Benefit Study

Author

Lee, Yeh Chen, King, Madeleine T, OʼConnell, Rachel L, Lanceley, Anne, Joly, Florence, Hilpert, Felix, Davis, Alison, Roncolato, Felicia T, Okamoto, Aikou, Bryce, Jane, Donnellan, Paul, Oza, Amit M, Avall-Lundqvist, Elisabeth, Berek, Jonathan S, Ledermann, Jonathan A, Berton, Dominique, Sehouli, Jalid, Feeney, Amanda, Kaminsky, Marie-Christine, Diamante, Katrina, Stockler, Martin R, and Friedlander, Michael L

Published
2022
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41. Patient-Reported Outcome Results From the Open-Label Phase III AURELIA Trial Evaluating Bevacizumab-Containing Therapy for Platinum-Resistant Ovarian Cancer

Author

Stockler, Martin R, Hilpert, Felix, Friedlander, Michael, King, Madeleine T, Wenzel, Lari, Lee, Chee Khoon, Joly, Florence, de Gregorio, Nikolaus, Arranz, José Angel, Mirza, Mansoor Raza, Sorio, Roberto, Freudensprung, Ulrich, Sneller, Vesna, Hales, Gill, and Pujade-Lauraine, Eric

Subjects
Cancer, Rare Diseases, Ovarian Cancer, Clinical Research, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Bevacizumab, Doxorubicin, Drug Administration Schedule, Drug Resistance, Neoplasm, Female, Humans, Middle Aged, Organoplatinum Compounds, Ovarian Neoplasms, Paclitaxel, Polyethylene Glycols, Self Report, Topotecan, Treatment Outcome, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeTo determine the effects of bevacizumab on patient-reported outcomes (PROs; secondary end point) in the AURELIA trial.Patients and methodsPatients with platinum-resistant ovarian cancer were randomly assigned to chemotherapy alone (CT) or with bevacizumab (BEV-CT). PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module 28 (EORTC QLQ-OV28) and Functional Assessment of Cancer Therapy-Ovarian Cancer symptom index (FOSI) at baseline and every two or three cycles (8/9 weeks) until disease progression. The primary PRO hypothesis was that more patients receiving BEV-CT than CT would achieve at least a 15% (≥ 15-point) absolute improvement on the QLQ-OV28 abdominal/GI symptom subscale (items 31-36) at week 8/9. Patients with missing week 8/9 questionnaires were included as unimproved. Questionnaires from all assessments until disease progression were analyzed using mixed-model repeated-measures (MMRM) analysis. Sensitivity analyses were used to determine the effects of differing assumptions and methods for missing data.ResultsBaseline questionnaires were available from 89% of 361 randomly assigned patients. More BEV-CT than CT patients achieved a ≥ 15% improvement in abdominal/GI symptoms at week 8/9 (primary PRO end point, 21.9% v 9.3%; difference, 12.7%; 95% CI, 4.4 to 20.9; P = .002). MMRM analysis covering all time points also favored BEV-CT (difference, 6.4 points; 95% CI, 1.3 to 11.6; P = .015). More BEV-CT than CT patients achieved ≥ 15% improvement in FOSI at week 8/9 (12.2% v 3.1%; difference, 9.0%; 95% CI, 2.9% to 15.2%; P = .003). Sensitivity analyses gave similar results and conclusions.ConclusionBevacizumab increased the proportion of patients achieving a 15% improvement in patient-reported abdominal/GI symptoms during chemotherapy for platinum-resistant ovarian cancer.

Published
2014

43. 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

Author

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

Published
2018

44. The EORTC CAT Core—The computer adaptive version of the EORTC QLQ-C30 questionnaire

Author

Petersen, Morten Aa., Aaronson, Neil K., Arraras, Juan I., Chie, Wei-Chu, Conroy, Thierry, Costantini, Anna, Dirven, Linda, Fayers, Peter, Gamper, Eva-Maria, Giesinger, Johannes M., Habets, Esther J.J., Hammerlid, Eva, Helbostad, Jorunn, Hjermstad, Marianne J., Holzner, Bernhard, Johnson, Colin, Kemmler, Georg, King, Madeleine T., Kaasa, Stein, Loge, Jon H., Reijneveld, Jaap C., Singer, Susanne, Taphoorn, Martin J.B., Thamsborg, Lise H., Tomaszewski, Krzysztof A., Velikova, Galina, Verdonck-de Leeuw, Irma M., Young, Teresa, and Groenvold, Mogens

Published
2018
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47. Validation of the modified Glasgow Prognostic Score (mGPS) in recurrent ovarian cancer (ROC) – Analysis of patients enrolled in the GCIG Symptom Benefit Study (SBS)

Author

Roncolato, Felicia T., Berton-Rigaud, Dominique, O'Connell, Rachel, Lanceley, Anne, Sehouli, Jalid, Buizen, Luke, Okamoto, Aikou, Aotani, Eriko, Lorusso, Domenica, Donnellan, Paul, Oza, Amit, Avall-Lundqvist, Elisabeth, Berek, Jonathan, Hilpert, Felix, Ledermann, Jonathan A., Kaminsky, Marie Christine, Stockler, Martin R., King, Madeleine T., and Friedlander, Michael

Published
2018
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