Clinician-reported symptomatic adverse events in cancer trials: are they concordant with patient-reported outcomes?

被引：6
|
作者：
Sparano, Francesco [1 ,2 ]
Aaronson, Neil K. [3 ]
Cottone, Francesco [1 ,2 ]
Piciocchi, Alfonso [1 ,2 ]
La Sala, Edoardo [1 ,2 ]
Anota, Amelie [4 ]
Deliu, Nina [1 ,2 ]
Kieffer, Jacobien M. [3 ]
Efficace, Fabio [1 ,2 ]
机构：
[1] Italian Grp Adult Hematol Dis GIMEMA, Ctr Data, Rome, Italy
[2] Hlth Outcomes Res Unit, Rome, Italy
[3] Netherlands Canc Inst, Dept Psychosocial Res, Div Psychosocial Res & Epidemiol, Amsterdam, Netherlands
[4] Univ Hosp Besancon, Qual Life Oncol French Natl Platform, Methodol & Qual Life Oncol Unit, INSERM,UMR 1098, Besancon, France
来源：
JOURNAL OF COMPARATIVE EFFECTIVENESS RESEARCH | 2019年 / 8卷 / 05期
关键词：
adverse events; cancer; patient-reported outcomes; randomized controlled trials; symptoms; RANDOMIZED CONTROLLED-TRIALS; COMMON TERMINOLOGY CRITERIA; QUALITY; AGREEMENT;
D O I：
10.2217/cer-2018-0092
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：
Aim: We investigate the concordance, in terms of favoring the same treatment arm, between clinician-reported symptomatic adverse events (AEs) and information obtained via patient-reported outcomes (PRO) measures in cancer randomized controlled trials (RCTs). Methods: We conducted a systematic literature search to identify all RCTs conducted in breast, colorectal, lung and prostate cancer, published between 2004 and 2017. Results: We identified 207 RCTs. In the majority of RCTs (n = 133, 64.2%) a discordance between PROs and AEs was found. In 104 studies (50.2%), PRO data favored the experimental arm when AEs did not, while the opposite situation was found in 29 trials (14.0%). Conclusion: Frequently, information obtained via PRO measures and clinician-reported AEs do not favor the same treatment arm in RCT settings.
引用
收藏
页码：279 / 288
页数：10
相关论文
共 50 条
  • [41] Frequency and distribution of gastrointestinal oncology patient-reported symptomatic adverse events (SAEs) at a comprehensive cancer center
    McCleary, Nadine Jackson
    Haakenstad, Ellana
    Cleveland, Jessica
    Zhang Sunyi
    Hassett, Michael J.
    Schrag, Deborah
    JOURNAL OF CLINICAL ONCOLOGY, 2021, 39 (03)
  • [42] Patient-reported and clinician-reported chemotherapy-induced peripheral neuropathy in patients with early breast cancer: Current clinical practice
    Nyrop, Kirsten A.
    Deal, Allison M.
    Reeder-Hayes, Kathryn E.
    Shachar, Shlomit S.
    Reeve, Bryce B.
    Basch, Ethan
    Choi, Seul Ki
    Lee, Jordan T.
    Wood, William A.
    Anders, Carey K.
    Carey, Lisa A.
    Dees, Elizabeth C.
    Jolly, Trevor A.
    Kimmick, Gretchen G.
    Karuturi, Meghan S.
    Reinbolt, Raquel E.
    Speca, JoEllen C.
    Muss, Hyman B.
    CANCER, 2019, 125 (17) : 2945 - 2954
  • [43] Reflections on estimands for patient-reported outcomes in cancer clinical trials
    Lawrance, Rachael
    Skaltsa, Konstantina
    Regnault, Antoine
    Floden, Lysbeth
    JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2023,
  • [44] Trustworthiness of Patient-Reported Outcomes in Unblinded Cancer Clinical Trials
    Atkinson, Thomas M.
    Wagner, Jan-Samuel
    Basch, Ethan
    JAMA ONCOLOGY, 2017, 3 (06) : 738 - 739
  • [45] The prognostic significance of patient-reported outcomes in cancer clinical trials
    Gotay, Carolyn C.
    Kawamoto, Crissy T.
    Bottomley, Andrew
    Efficace, Fabio
    JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (08) : 1355 - 1363
  • [46] PATIENT-REPORTED OUTCOMES (PROS) IN OVARIAN CANCER CLINICAL TRIALS
    Pease, S.
    Barsdorf, A., I
    VALUE IN HEALTH, 2015, 18 (03) : A210 - A210
  • [47] Patient-Reported Outcomes: Comprehensive Analysis for the Oculofacial Clinician
    Ramey, Nicholas A.
    Butt, Zeeshan
    Burkat, Cat N.
    Rose, John G.
    Lucarelli, Mark J.
    OPHTHALMIC PLASTIC AND RECONSTRUCTIVE SURGERY, 2014, 30 (04): : 279 - 289
  • [48] ASSESSING CELLULITE SEVERITY: METHOD FOR ASSESSING RELIABILITY OF A NEW CLINICIAN-REPORTED AND A NEW PATIENT-REPORTED PHOTONUMERIC SCALE
    Kirby, M. T.
    McLane, M. P.
    Lenderking, W. R.
    Bender, R.
    Chen, J.
    Hurley, D.
    Knoble, N.
    Liu, G.
    Davidson, J. A.
    VALUE IN HEALTH, 2018, 21 : S229 - S229
  • [49] Clinician-reported PASI versus patient-reported symptoms and signs in moderate to severe psoriasis patients: Voyage 1&2 clinical trials
    Gordon, K.
    Han, C.
    Li, S.
    You, Y.
    Song, M.
    Fakharzadeh, S.
    Crowley, J.
    Reich, K.
    AUSTRALASIAN JOURNAL OF DERMATOLOGY, 2019, 60 : 42 - 42
  • [50] Electronic capture of patient-reported and clinician-reported outcome measures in an elective orthopaedic setting: a retrospective cohort analysis
    Malhotra, Karan
    Buraimoh, Olatunbosun
    Thornton, James
    Cullen, Nicholas
    Singh, Dishan
    Goldberg, Andrew J.
    BMJ OPEN, 2016, 6 (06):
12345