Patient-reported outcomes in randomised controlled trials of gynaecological cancers: Investigating methodological quality and impact on clinical decision-making |
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| Affiliation: | 1. Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy;2. Academic Medical Center, University of Amsterdam, Department of Medical Psychology, Amsterdam, The Netherlands;3. Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, USA;4. Department of Obstetrics and Gynecology, Medical University of Graz, Graz, Austria;5. Division of Psychosocial Research & Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands;6. Leeds Institute of Cancer Studies and Pathology, University of Leeds, Leeds, UK;7. Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK;8. Centre for Surgical Research, University of Bristol and University Hospitals NHS Foundation Trust, Bristol, UK;1. British Columbia Cancer Agency, University of British Columbia, Vancouver, BC, Canada;2. Tom Baker Cancer Centre, Calgary, AB, Canada;3. University Health Network-Princess Margaret Cancer Centre, Toronto, ON, Canada;4. Cross Cancer Institute, Edmonton, AB, Canada;1. Department of Gastroenterology, Hospital Clínic Barcelona, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Spain;2. Pathology Department, Centre de Diagnòstic Biomèdic, Hospital Clinic, University of Barcelona, and Banc de Tumors-Biobanc Clinic-IDIBAPS, Spain;3. Medical Oncology Department, Hospital Miguel Servet, Zaragoza, Spain;4. Medical Oncology Department, Hospital Clínico de Zaragoza, Spain;5. Medical Oncology Department, Hospital Clínic Barcelona, Spain;6. Pathology Department, Hospital Miguel Servet, Zaragoza, Spain;7. Pathology Department, Hospital Clinico Zaragoza, Spain;8. Department of Epidemiology, Harvard Medical School of Public Health, Boston, USA;9. Bioinformatics Unit, CIBERehd, Barcelona, Catalonia, Spain;10. Catalan Institute of Oncology, Hospital Germans Trias i Pujol, Badalona, Spain;1. Division of Pathology, Research Center for Innovative Oncology, National Cancer Center Hospital East, Japan;2. Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital East, Japan;3. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Japan;4. Department of Surgery, Toho University School of Medicine, Japan;1. Department of Nuclear Medicine, Saint-Louis Hospital, Paris, France;2. B2T, Doctoral School, IUH, University of Paris VII, France;3. Department of Nuclear Medicine, CHU Bordeaux, University of Bordeaux, France;4. Breast Diseases Unit and Department of Medical Oncology, Saint-Louis Hospital, Paris, France;5. Department of Biostatistics, Institut Curie, Paris, France;6. Department of Pathology, Saint-Louis Hospital, Paris, France;7. Department of Biochemistry, Saint-Louis Hospital, Paris, France;8. Centre for Therapeutic Innovation, Saint Louis Hospital, Paris, France;9. INSERM, UMR 1101 LaTIM, Brest, France;1. Department of Pathology, Ludwig-Maximilians-University of Munich, Germany;2. Department of Internal Medicine III and Comprehensive Cancer Center, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, Germany;3. German Cancer Consortium (DKTK), Heidelberg, Germany;4. German Cancer Research Center (DKFZ), Heidelberg, Germany;5. Clovis Oncology Inc., San Francisco, CA, USA;6. Institute of Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilians-University of Munich, Germany;7. Department of General, Visceral, Transplantation, Vascular and Thoracic Surgery, Klinikum Grosshadern, Ludwig-Maximilians-University of Munich, Germany |
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| Abstract: | AimThe aim for this study is to investigate the methodological quality and potential impact on clinical decision making of patient reported outcome (PRO) assessment in randomised controlled trials (RCTs) in the gynaecological cancer sites.MethodsA systematic review identified RCTs published between January 2004 and June 2012. Relevant studies were evaluated using a pre-determined extraction form which included: (1) Trial demographics and clinical and PRO characteristics; (2) level of PRO reporting and (3) bias, assessed using the Cochrane Risk of Bias tool. All studies were additionally analysed in relation to their relevance in supporting clinical decision making.ResultsFifty RCTs enrolling 24,991 patients were identified. In eight RCTs (16%) a PRO was the primary end-point. Twenty-one studies (42%) were carried out in a multi-national context. Where statistically significant PRO differences between treatments were found, it related in most cases to both symptoms and domains other than symptoms (n = 17, 57%). The majority of studies (n = 42, 84%) did not mention the mode of administration nor the methods of collecting PRO data. Statistical approaches for dealing with missing data were only explicitly mentioned in nine RCTs (18%). Sixteen RCTs (32%) were considered to be of high-quality and thus able to inform clinical decision making. Higher-quality PRO studies were generally associated with RCTs that were at a low risk of bias.ConclusionThis study showed that RCTs with PROs were generally well designed and conducted. In a third the information was very informative to fully understand the pros and cons of PROs treatment decision-making. |
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| Keywords: | Gynaecologic cancer Patient-reported outcomes Clinical trials Quality of life Clinical decision-making |
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