(Press-News.org) TAMPA, Fla. — Patient-reported outcomes are important indicators of how cancer drugs impact patients’ lives. By assessing the benefits and risks of drugs from a patient’s perspective, scientists and physicians can improve the development of patient-centered drugs and care. In a recent study published in eClinicalMedicine, part of The Lancet Discovery Science, Moffitt Cancer Center researchers demonstrate that there is a significant unmet need for improved analyses and reporting of patient-reported outcomes in genitourinary cancer clinical trials.
Health care professionals have realized that how a disease and its treatment impact a patient’s life are critical factors to consider when choosing treatment. A therapy may improve survival; however, if its side effects are too great and impact a patient’s quality of life, that drug may not be an optimal choice. Patient-reported outcomes are reports from patients about their own health status and quality of life that take into account their disease, the treatment they are receiving, and other personal factors. Patient-reported outcomes can include questions from side effects of treatment to financial concerns and access to caregiver support.
The Moffitt researchers wanted to assess the quality of patient-reported outcomes data collected in clinical trials that led to the approval of genitourinary cancer therapies. Genitourinary cancers affect over 444,000 people each year in the United States. They are among the most common malignant diseases in men, including prostate, bladder and kidney cancers. Chemotherapy has traditionally been the standard treatment option for patients with genitourinary cancers; however, within the past 15 years, many new targeted treatment options have been approved based on improvements in outcomes such as overall survival and response rates. Patient-reported outcomes are often analyzed in cancer clinical trials but the quality of these analyses in genitourinary clinical trials is unknown.
The team conducted a systematic review of data that led to genitourinary cancer drug FDA approvals from February 2007 to July 2022 and identified 40 clinical trials that met inclusion criteria. They analyzed the clinical trial protocols and compared what was intended in the study to what patient-reported outcomes data was presented and published. The researchers then analyzed the quality of the patient-reported outcomes data based on a scoring scheme they developed.
The researchers found that only 67.5% of the trial publications reported patient-reported outcomes data, including 10% that reported preliminary patient-reported outcomes data in the primary clinical trial publication and 57.5% that reported patient-reported outcomes data in a secondary publication. Of the 40 clinical trials, 31 planned to collect patient-reported outcomes data, while nine did not. The median time between the primary clinical trial publication and the publication of the patient-reported outcome was 10.5 months. The researchers found that the type of patient-reported outcomes data that was collected, and the statistical analyses used to analyze the data varied greatly among the studies, and many trials still needed to perform a quality analysis. The mean quality score of the patient-reported outcomes data was 11.10 (range of 6–24) out of a possible 24 total points.
These combined data reveal that patient-reported outcomes data is often not collected in a timely manner or of the highest quality. The researchers hope their analysis will improve clinical trial design and approaches to collecting and analyzing patient-reported outcomes data to improve patient outcomes and quality of life.
“Our data showed a considerable gap in reporting patient-reported outcomes and in the quality of design and conduct of patient-reported outcomes-related trial endpoints. With the expanding array of therapies for genitourinary malignancies, the accessibility and clear presentation of patient-reported outcomes data are also essential for tailoring personalized treatment plans for patients, highlighting the crucial need for improved reporting and accessibility of this information,” explained Jad Chahoud, M.D., MPH, assistant member of the Department of Genitourinary Oncology at Moffitt.
This work was supported by the National Cancer Institute (P30-CA076292) and the R.S. Evans Foundation.
About Moffitt Cancer Center
Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 56 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt’s expert nursing staff is recognized by the American Nurses Credentialing Center with Magnet® status, its highest distinction. With more than 9,000 team members, Moffitt has an economic impact in the state of $2.4 billion. For more information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the momentum on Facebook, Twitter, Instagram and YouTube.
###
Paravathaneni, M., Safa, H., Joshi, V. B., Tamil, M., Adashek, J. J., Ionescu, F., Shah, S., Chadha, J., Gilbert, S. M., Manley, B. J., Semaan, A., Jim, H., Kalos, D., Kim, Y. C., Spiess, P. E., & Chahoud, J. (2024). 15 years of patient-reported outcomes in clinical trials leading to GU cancer drug approvals: a systematic review on the quality of data reporting and analysis. eClinicalMedicine, 68, 102413. https://doi.org/10.1016/j.eclinm.2023.102413
END
In December 2023, the new "FOOD includes" project funded by the European Commission started at the Center for Lifelong Learning at Johannes Gutenberg University Mainz (JGU). Over its 36-month term, the objective of "FOOD includes" is to increase take-up and improve the inclusiveness and accessibility of adult education. The project has been designed for adults with lower academic qualifications and migrants who are less likely to take advantage of continuing education and training opportunities. Therefore, the project focuses on activities revolving ...
The waste in our water could soon generate new waves of clean energy development, job creation and economic growth across the Great Lakes thanks to a new regional innovation and economic development initiative launched by the U.S. National Science Foundation (NSF). The initiative will fund efforts to find new ways to recover clean water, nutrients and materials for clean energy technologies from wastewater — all while removing dangerous chemicals.
These efforts will be carried out by Great Lakes ReNEW, a collaboration of research institutions, universities, ...
In the human body, the lungs and their vasculature can be likened to a building with an intricate plumbing system. The lungs’ blood vessels are the pipes essential for transporting blood and nutrients for oxygen delivery and carbon dioxide removal. Much like how pipes can get rusty or clogged, disrupting normal water flow, damage from respiratory viruses, like SARS-CoV-2 or influenza, can interfere with this “plumbing system.”
In a recent study, researchers looked at the critical role of vascular ...
COLUMBIA, Mo. -- Christi Bergin has devoted 40 years of her life to helping teachers and their students. Throughout her career, she’s noticed two simultaneous trends in the field that seem to be connected: a rise in disruptive classroom behavior, and an exodus of teachers from the profession who leave due to stress and burnout.
To help combat these trends, Bergin, a professor emerita in the University of Missouri College of Education and Human Development, has focused her research on improving prosocial behavior — actions that show kindness, compassion, empathy and respect — in classrooms and communities.
Not ...
Black men with firearm-acquired disabilities face negative physical and psychological impacts on their manhood, independence and mobility, according to a Rutgers Health study.
The study, published in the American Journal of Men’s Health, explored the relationship between Black manhood/masculinities and firearm-acquired disabilities. Participants’ disabilities also impacted their perceptions of independence. Specifically, participants felt that they were a burden to their caretakers because of their reliance on them. This loss of independence ...
Researchers have discovered two new freshwater hyphomycete (mould) species, Acrogenospora alangii and Conioscypha yunnanensis, in southwestern China.
This discovery, detailed in a study published in MycoKeys, marks the addition of these species to the Acrogenospora and Conioscypha genera, further enriching the diversity of freshwater fungi known in the region.
A research team consisting of Lu Li, Hong-Zhi Du and Ratchadawan Cheewangkoon from Chiang Mai University, Thailand, as well as Vinodhini Thiyagaraja and Rungtiwa Phookamsak from Kunming Institute of Botany, China, and Darbhe Jayarama Bhat from King Saud University, Saudi Arabia, employed comprehensive morphological ...
A Colorado State University experiment spanning more than two decades has found that removal of apex predators from an ecosystem can create lasting changes that are not reversed after they return – at least, not for a very long time.
The study, funded by the National Science Foundation and published in Ecological Monographs, challenges the commonly held belief that the reintroduction of wolves to Yellowstone National Park restored an ecosystem degraded by their absence.
Researchers in CSU’s Warner College of Natural Resources ...
A new paper in the Quarterly Journal of Economics, published by Oxford University Press, finds that a new form of digital technology—essentially preventing people from using an asset for which they have a loan if they don’t make payments, rather than repossessing the asset itself—may be a better way for lenders to secure loans, particularly for loan recipients in developing countries.
Using collateral to secure debt helps overcome economic frictions, lowering the cost of providing credit. More than 80% of total household debt in the United States is secured by ...
Evanston, IL—The International Society for Stem Cell Research (ISSCR) will award its 2024 ISSCR Achievement Award to Fiona M. Watt, D.Phil., F.R.S., F.Med.Sci., EMBO Director and leader of a research group at EMBL - Heidelberg, Germany. The award recognizes the transformative body of work of an investigator that has had a major impact on the field of stem cell research or regenerative medicine. Dr. Watt will present her research during Plenary VII on 13 July at the ISSCR 2024 Annual Meeting in Hamburg, Germany. ISSCR 2024 is the world’s leading gathering of the brightest minds in stem cell research and cell and regenerative medicine.
“Fiona is a giant in stem cell ...
Evanston, IL—The International Society for Stem Cell Research (ISSCR) is honoring Jun Wu, Ph.D. with the 2024 ISSCR Outstanding Young Investigator Award. Dr. Wu is an associate professor in the Department of Molecular Biology at the University of Texas Southwestern Medical Center, U.S.A. and a New York Stem Cell Foundation–Robertson Investigator.
The award recognizes the exceptional achievements of an investigator in the early part of his or her independent career in stem cell research. Dr. Wu will present his work during Plenary II, New Technologies to Engineer and Phenotype Stem Cell Systems, on 10 July during the ISSCR 2024 Annual Meeting taking place in Hamburg, Germany. ...
