Impact of open-label versus blinded study design on patient-reported outcomes data in randomized clinical trials of immunotherapy in advanced or metastatic cancer patients: a systematic review

被引：0
|
作者：
Amélie Anota
Astrid Pozet
Hervé Lemasson
Francois-Emery Cotté
Antoine Falcoz
Guillaume Eberst
Guillaume Mouillet
Stéphane Guerzider
Émilie Charton
Virginie Westeel
机构：
[1] University Hospital of Besançon,Methodology and Quality of Life Unit in Oncology (INSERM UMR 1098)
[2] French National Platform Quality of Life and Cancer,Chest Disease Department
[3] Bristol-Myers Squibb,undefined
[4] University Hospital of Besançon,undefined
来源：
Quality of Life Research | 2022年 / 31卷
关键词：
Bias; Immuno-oncology; Open label; Patient-reported outcomes; Quality of life; Randomized controlled trials;
D O I：
暂无
中图分类号：
学科分类号：
摘要：
引用
收藏
页码：645 / 657
页数：12
相关论文
共 50 条
  • [41] Systematic Review of Radiation Therapy Toxicity Reporting in Randomized Controlled Trials of Rectal Cancer: A Comparison of Patient-Reported Outcomes and Clinician Toxicity Reporting
    Gilbert, Alexandra
    Ziegler, Lucy
    Martland, Maisie
    Davidson, Susan
    Efficace, Fabio
    Sebag-Montefiore, David
    Velikova, Galina
    INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 2015, 92 (03): : 555 - 567
  • [42] Sustained improvements in patient-reported outcomes after long-term sutimlimab in patients with cold agglutinin disease: results from the CADENZA study open-label extension
    Roeth, Alexander
    Broome, Catherine M.
    Barcellini, Wilma
    Jilma, Bernd
    Hill, Quentin A.
    Cella, David
    Tvedt, Tor Henrik Anderson
    Yamaguchi, Masaki
    Murakhovskaya, Irina
    Lee, Michelle
    Shafer, Frank
    Wardecki, Marek
    Jayawardene, Deepthi
    Yoo, Ronnie
    Msihid, Jerome
    Weitz, Ilene C.
    ECLINICALMEDICINE, 2024, 74
  • [43] Patient-Reported Outcomes from a 16-Week Open-Label, Multicenter Study of Insulin Pump Therapy in Patients with Type 2 Diabetes Mellitus
    Rubin, Richard R.
    Peyrot, Mark
    Chen, Xiaojing
    Frias, Juan P.
    DIABETES TECHNOLOGY & THERAPEUTICS, 2010, 12 (11) : 901 - 906
  • [44] Patient-Reported Outcomes from a Randomized, Active-Controlled, Open-Label, Phase 3 Trial of Burosumab Versus Conventional Therapy in Children with X-Linked Hypophosphatemia
    Padidela, Raja
    Whyte, Michael P.
    Glorieux, Francis H.
    Munns, Craig F.
    Ward, Leanne M.
    Nilsson, Ola
    Portale, Anthony A.
    Simmons, Jill H.
    Namba, Noriyuki
    Cheong, Hae Il
    Pitukcheewanont, Pisit
    Sochett, Etienne
    Hogler, Wolfgang
    Muroya, Koji
    Tanaka, Hiroyuki
    Gottesman, Gary S.
    Biggin, Andrew
    Perwad, Farzana
    Williams, Angela
    Nixon, Annabel
    Sun, Wei
    Chen, Angel
    Skrinar, Alison
    Imel, Erik A.
    CALCIFIED TISSUE INTERNATIONAL, 2021, 108 (05) : 622 - 633
  • [45] Patient-Reported Outcomes from a Randomized, Active-Controlled, Open-Label, Phase 3 Trial of Burosumab Versus Conventional Therapy in Children with X-Linked Hypophosphatemia
    Raja Padidela
    Michael P. Whyte
    Francis H. Glorieux
    Craig F. Munns
    Leanne M. Ward
    Ola Nilsson
    Anthony A. Portale
    Jill H. Simmons
    Noriyuki Namba
    Hae Il Cheong
    Pisit Pitukcheewanont
    Etienne Sochett
    Wolfgang Högler
    Koji Muroya
    Hiroyuki Tanaka
    Gary S. Gottesman
    Andrew Biggin
    Farzana Perwad
    Angela Williams
    Annabel Nixon
    Wei Sun
    Angel Chen
    Alison Skrinar
    Erik A. Imel
    Calcified Tissue International, 2021, 108 : 622 - 633
  • [46] Evaluating the impact of calibration of patient-reported outcomes measures on results from randomized clinical trials: a simulation study based on Rasch measurement theory
    Angély Loubert
    Antoine Regnault
    Véronique Sébille
    Jean-Benoit Hardouin
    BMC Medical Research Methodology, 22
  • [47] Patient-reported outcomes with atezolizumab plus bevacizumab versus sorafenib in patients with unresectable hepatocellular carcinoma (IMbrave150): an open-label, randomised, phase 3 trial
    Galle, Peter R.
    Finn, Richard S.
    Qin, Shukui
    Ikeda, Masafumi
    Zhu, Andrew X.
    Kim, Tae-You
    Kudo, Masatoshi
    Breder, Valeriy
    Merle, Philippe
    Kaseb, Ahmed
    Li, Daneng
    Mulla, Sohail
    Verret, Wendy
    Xu, Derek-Zhen
    Hernandez, Sairy
    Ding, Beiying
    Liu, Juan
    Huang, Chen
    Lim, Ho Yeong
    Cheng, Ann-Lii
    Ducreux, Michel
    LANCET ONCOLOGY, 2021, 22 (07) : 991 - 1001
  • [48] Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase III study
    Goldman, Jonathan W.
    Garassino, Marina Chiara
    Chen, Yuanbin
    Ozguroglu, Mustafa
    Dvorkin, Mikhail
    Trukhin, Dmytro
    Statsenko, Galina
    Hotta, Katsuyuki
    Ji, Jun Ho
    Hochmair, Maximilian J.
    Voitko, Oleksandr
    Havel, Libor
    Poltoratskiy, Artem
    Losonczy, Gyorgy
    Reinmuth, Niels
    Patel, Nikunj
    Laud, Peter J.
    Shire, Norah
    Jiang, Haiyi
    Paz-Ares, Luis
    LUNG CANCER, 2020, 149 : 46 - 52
  • [49] Evaluating the impact of calibration of patient-reported outcomes measures on results from randomized clinical trials: a simulation study based on Rasch measurement theory
    Loubert, Angely
    Regnault, Antoine
    Sebille, Veronique
    Hardouin, Jean-Benoit
    BMC MEDICAL RESEARCH METHODOLOGY, 2022, 22 (01)
  • [50] Predictors for improvement in patient-reported outcomes: post hoc analysis of a phase 3 randomized, open-label study of eculizumab and ravulizumab in complement inhibitor-naive patients with paroxysmal nocturnal hemoglobinuria
    Hubert Schrezenmeier
    Austin Kulasekararaj
    Lindsay Mitchell
    Régis Peffault de Latour
    Timothy Devos
    Shinichiro Okamoto
    Richard Wells
    Evan Popoff
    Antoinette Cheung
    Alice Wang
    Ioannis Tomazos
    Yogesh Patel
    Jong Wook Lee
    Annals of Hematology, 2024, 103 : 5 - 15
12345