• About
  • Masthead
  • License Content
  • Advertise
  • Submit Press Release
  • RSS/Email List
  • Write for us
  • Contact us
2 Minute Medicine
No Result
View All Result

No products in the cart.

SUBSCRIBE
  • Specialties
    • Cardiology
    • Chronic Disease
    • Dermatology
    • Emergency
    • Endocrinology
    • Gastroenterology
    • Imaging and Intervention
    • Infectious Disease
    • Nephrology
    • Neurology
    • Obstetrics
    • Oncology
    • Ophthalmology
    • Pediatrics
    • Preclinical
    • Psychiatry
    • Public Health
    • Pulmonology
    • Rheumatology
    • Surgery
  • Wellness
  • Classics™
    • 2MM+ Online Access
    • Paperback and Ebook
  • Rewinds
  • Visual
  • Partners
    • License Content
    • Submit Press Release
    • Advertise with Us
  • AccountLog-in/out
    • Subscribe
    • Sign-in
    • My account
2 Minute Medicine
  • Specialties
    • Cardiology
    • Chronic Disease
    • Dermatology
    • Emergency
    • Endocrinology
    • Gastroenterology
    • Imaging and Intervention
    • Infectious Disease
    • Nephrology
    • Neurology
    • Obstetrics
    • Oncology
    • Ophthalmology
    • Pediatrics
    • Preclinical
    • Psychiatry
    • Public Health
    • Pulmonology
    • Rheumatology
    • Surgery
  • Wellness
  • Classics™
    • 2MM+ Online Access
    • Paperback and Ebook
  • Rewinds
  • Visual
  • Partners
    • License Content
    • Submit Press Release
    • Advertise with Us
  • AccountLog-in/out
    • Subscribe
    • Sign-in
    • My account
SUBSCRIBE
2 Minute Medicine
Subscribe
Home All Specialties Oncology

Clinician vs Patient Reporting of Baseline and Post-Baseline Symptoms for Adverse Event Assessment in Cancer Clinical Trials

byJack LennonandAliya Ramjaun
January 13, 2020
in Oncology, Public Health
Reading Time: 2 mins read
0
Share on FacebookShare on Twitter

RELATED REPORTS

Age-based products and longer interdose intervals may reduce the risk of cardiac disease following COVID-19 mRNA vaccination

#VisualAbstract: Bimekizumab shows a favourable 2-year safety profile in patients with moderate to severe plaque psoriasis

#VisualAbstract An ixazomib-based regimen may be a better-tolerated approach in elderly patients with newly diagnosed multiple myeloma

1. Across 26 cancer clinical trials, researchers detected fewer baseline symptoms than those reported by patients, suggesting that adjustments to baseline determinations in clinical trials should consider patient reports as reliable data points.

Evidence Rating Level: 2 (Good)

Baseline symptoms are an important consideration in oncologic clinical trials. Currently, the standard process of determining adverse events (AEs) is the Common Terminology Criteria for Adverse Events (CTCAE), however, this does not account, in a clear manner, events attributable to baseline symptoms and those arising during clinical trials. As such, it is important to account for patient-reported baseline symptoms to adjust analyses of adverse events that are specific to the trials themselves. This retrospective study of legacy clinical trials supported by the National Cancer Institute aimed to analyze clinician CTCAE as well as patient-reported outcome (PRO) questionnaires both at baseline and throughout the clinical trials. A total of 26 cancer clinical trials between 1996 and 2015 were identified, with 24 unique AEs captured with the PRO questionnaires and other specific symptom scales. Baseline scores were significantly higher on patient reports compared to clinicians (83% of symptoms differed). Worst-case postbaseline symptom rates, independent of baseline adjustments, were different between patients and clinicians in 88% of reported symptoms, 76% of which were higher according to the patients. Importantly, approximately 67% of reported symptoms were significantly different between patients and clinicians when accounting for baseline symptoms, only 56% of which were rated higher by patients. This study highlights that nearly 75% of patients report a higher number of baseline symptoms than clinicians, such that misattribution of symptoms to trial effects may be overestimated. However, if sufficient patient reports are obtained and adjustment methods are utilized in accordance with this study, this discrepancy is reduced to roughly 50% disagreement and may reduce error in determining trial effects and AEs.

Click to read the study in JAMA Oncology

Image: PD

©2019 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.

Tags: adverse eventsclinical trialnew drug application
Previous Post

Coronary Sinus Neuropeptide Y Levels and Adverse Outcomes in Patients With Stable Chronic Heart Failure

Next Post

2 Minute Medicine Rewind January 13, 2020

RelatedReports

Novel coronavirus identified from patients with pneumonia in Wuhan, China
Cardiology

Age-based products and longer interdose intervals may reduce the risk of cardiac disease following COVID-19 mRNA vaccination

June 30, 2022
#VisualAbstract: Bimekizumab shows a favourable 2-year safety profile in patients with moderate to severe plaque psoriasis
StudyGraphics

#VisualAbstract: Bimekizumab shows a favourable 2-year safety profile in patients with moderate to severe plaque psoriasis

May 27, 2022
#VisualAbstract An ixazomib-based regimen may be a better-tolerated approach in elderly patients with newly diagnosed multiple myeloma
StudyGraphics

#VisualAbstract An ixazomib-based regimen may be a better-tolerated approach in elderly patients with newly diagnosed multiple myeloma

December 18, 2021
#VisualAbstract Assessing early tumour response and immune-related adverse events when undergoing combination nivolumab and ipilimumab therapy for advanced melanoma
StudyGraphics

#VisualAbstract Assessing early tumour response and immune-related adverse events when undergoing combination nivolumab and ipilimumab therapy for advanced melanoma

November 18, 2021
Next Post
Cerebral protection device effective in patients undergoing transcatheter aortic valve implantation

2 Minute Medicine Rewind January 13, 2020

Mortality and Health Care Utilization Among Medicare Patients Undergoing Emergency General Surgery vs Those With Acute Medical Conditions

Quick Take: Diagnostic Yield of One-Time Colonoscopy vs One-Time Flexible Sigmoidoscopy vs Multiple Rounds of Mailed Fecal Immunohistochemical Tests in Colorectal Cancer Screening

Comparative Effectiveness of Proton vs Photon Therapy as Part of Concurrent Chemoradiotherapy for Locally Advanced Cancer

License Our Award-Winning Physician-Written Medical News and Visual Abstracts

2 Minute Medicine is the leading authoritative medical news licensing service, and the only with reports written by practicing doctors.

LICENSE CONTENT

2MM+ Premium Access

No ads & unlimited access to all current reports, over 9000 searchable archived reports, visual abstracts, Weekly Rewinds, and the online edition of The Classics Series™ textbook.

Subscription Options
2 Minute Medicine

2 Minute Medicine® is an award winning, physician-run, expert medical media company. Our content is curated, written and edited by practicing health professionals who have clinical and scientific expertise in their field of reporting. Our editorial management team is comprised of highly-trained MD physicians. Join numerous brands, companies, and hospitals who trust our licensed content.

Recent Reports

  • Cognitive behavioral therapy efficacious for treatment of comorbid posttraumatic headache and posttraumatic stress disorder symptoms among US veterans
  • Sickle cell trait associated with preexisting kidney comorbidities and increased COVID-19 mortality
  • Adding atezolizumab to standard of care treatment for human epidermal growth factor receptor 2 (HER2) positive early breast cancer does not improve pathologic response outcomes
License Content
Terms of Use | Disclaimer
Cookie Policy
Privacy Statement (EU)
Disclaimer

© 2021 2 Minute Medicine, Inc. - Physician-written medical news.

  • Specialties
    • Cardiology
    • Chronic Disease
    • Dermatology
    • Emergency
    • Endocrinology
    • Gastroenterology
    • Imaging and Intervention
    • Infectious Disease
    • Nephrology
    • Neurology
    • Obstetrics
    • Oncology
    • Ophthalmology
    • Pediatrics
    • Preclinical
    • Psychiatry
    • Public Health
    • Pulmonology
    • Rheumatology
    • Surgery
  • Wellness
  • Classics™
    • 2MM+ Online Access
    • Paperback and Ebook
  • Rewinds
  • Visual
  • Partners
    • License Content
    • Submit Press Release
    • Advertise with Us
  • Account
    • Subscribe
    • Sign-in
    • My account

© 2021 2 Minute Medicine, Inc. - Physician-written medical news.