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
  • [1] Use of Patient-Reported Outcomes to Improve the Predictive Accuracy of Clinician-Reported Adverse Events
    Basch, Ethan
    Bennett, Antonia
    Pietanza, M. Catherine
    JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2011, 103 (24) : 1808 - 1810
  • [2] Patient-reported outcomes corresponding to most common symptomatic adverse events in lung cancer clinical trials
    Horodniceanu, Erica
    Datla, Tejaswi
    Larkins, Erin A.
    Singh, Harpreet
    Kluetz, Paul Gustav
    Bhatnagar, Vishal
    JOURNAL OF CLINICAL ONCOLOGY, 2024, 42 (16)
  • [3] How accurate is physicians' rating of generic toxicity burden of cancer clinical trials? A comparison with clinician-reported adverse events data and patient-reported quality of life
    Koehler, M.
    von Toll, T.
    Fischer, T.
    Frommer, J.
    ONKOLOGIE, 2010, 33 : 180 - 180
  • [4] Correlation of clinician-reported outcomes with patient-reported outcomes by race and ethnicity in patients with atopic dermatitis
    Smith, Jourdan Hydol
    Silverberg, Jonathan I.
    JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2023, 89 (03) : 579 - 580
  • [5] Clinical Relevance of Routine Monitoring of Patient-reported Outcomes Versus Clinician-reported Outcomes in Oncology
    Fiteni, Frederic
    Cuenant, Alice
    Favier, Mireille
    Cousin, Christelle
    Houede, Nadine
    IN VIVO, 2019, 33 (01): : 17 - 21
  • [6] Clinician-reported childbirth outcomes, patient-reported childbirth trauma, and risk for postpartum depression
    Waller, Rebecca
    Kornfield, Sara L.
    White, Lauren K.
    Chaiyachati, Barbara H.
    Barzilay, Ran
    Njoroge, Wanjiku
    Parish-Morris, Julia
    Duncan, Andrea
    Himes, Megan M.
    Rodriguez, Yuheiry
    Seidlitz, Jakob
    Riis, Valerie
    Burris, Heather H.
    Gur, Raquel E.
    Elovitz, Michal A.
    ARCHIVES OF WOMENS MENTAL HEALTH, 2022, 25 (05) : 985 - 993
  • [7] Clinician-reported childbirth outcomes, patient-reported childbirth trauma, and risk for postpartum depression
    Rebecca Waller
    Sara L. Kornfield
    Lauren K. White
    Barbara H. Chaiyachati
    Ran Barzilay
    Wanjikũ Njoroge
    Julia Parish-Morris
    Andrea Duncan
    Megan M. Himes
    Yuheiry Rodriguez
    Jakob Seidlitz
    Valerie Riis
    Heather H. Burris
    Raquel E. Gur
    Michal A. Elovitz
    Archives of Women's Mental Health, 2022, 25 : 985 - 993
  • [8] VALUE OF PATIENT-REPORTED OUTCOMES (PROS) VERSUS CLINICIAN-REPORTED OUTCOMES (CROS) IN 3 CHRONIC DISEASES
    Chassany, Olivier
    Le Jeunne, Philippe
    QUALITY OF LIFE RESEARCH, 2004, 13 (09) : 1513 - 1513
  • [9] The effect of collaborative reviews of electronic patient-reported outcomes on congruence of patient- and clinician-reported toxicity
    Trojan, A.
    Leuthold, N.
    Thomssen, C.
    Rody, A.
    Winder, T.
    Jakob, A.
    Egger, C.
    Held, U.
    Jackisch, C.
    SWISS MEDICAL WEEKLY, 2021, 151 : 36 - 37
  • [10] Clinician-reported lesion measurements in skin infection trials: Definitions, reliability, and association with patient-reported pain
    Powers, John H., III
    Das, Anita F.
    De Anda, Carisa
    Prokocimer, Philippe
    CONTEMPORARY CLINICAL TRIALS, 2016, 50 : 265 - 272
12345