Abstract
Introduction: Ovarian cancer is a major cause of death among women worldwide. Clinical trials are conducted by researchers to find safe and effective treatment for ovarian cancer patients. Evidence generated from these trials is intended to guide clinical practice and improve patient outcomes; however, the lack of standardized outcomes creates challenges for physicians when comparing treatment results. To address this issue, the Gynecologic Cancer Intergroup published a set of standardized outcomes in 2011, aiming to improve outcome reporting and support evidence- based decision making for physicians.
Objective: This study aimed to evaluate the uptake of the core outcome set recommended for ovarian cancer clinical trials.
Methods: We identified the initial ovarian cancer core outcome set (COS) from the Core Outcome Measures in Effectiveness Trials database. On June 29, 2023, we conducted a search of ovarian cancer clinical trial registries on the Clinicaltrials.gov database and identified which trials measured overall survival (OS), progression-free survival (PFS), toxicity, patient-reported outcomes (PRO), and time without symptoms (TWiST). We assessed the COS uptake in registries ranging from 2006 to 2023. Data screening and extraction was performed in a masked and duplicate manner.
Results: There was no uptake in core outcomes listed on trial registries after the 2011 COS publication. OS, PFS, PRO, and toxicity were consistently reported at high rates, ranging from 75.7%-89.6%. TWiST, however, was listed in only 2.9% of registries, indicating a deficiency in data reporting.
Discussion: The incomplete reporting of the full COS poses challenges for physicians and patients in comprehending outcomes and quality of life, making it difficult to make comparisons between different treatments. The limited adherence to the COS is thought to be attributed to the lack of awareness. To address this issue, there is a crucial need to increase awareness and promote the uptake of the COS, ensuring consistent and relevant reporting.
Objective: This study aimed to evaluate the uptake of the core outcome set recommended for ovarian cancer clinical trials.
Methods: We identified the initial ovarian cancer core outcome set (COS) from the Core Outcome Measures in Effectiveness Trials database. On June 29, 2023, we conducted a search of ovarian cancer clinical trial registries on the Clinicaltrials.gov database and identified which trials measured overall survival (OS), progression-free survival (PFS), toxicity, patient-reported outcomes (PRO), and time without symptoms (TWiST). We assessed the COS uptake in registries ranging from 2006 to 2023. Data screening and extraction was performed in a masked and duplicate manner.
Results: There was no uptake in core outcomes listed on trial registries after the 2011 COS publication. OS, PFS, PRO, and toxicity were consistently reported at high rates, ranging from 75.7%-89.6%. TWiST, however, was listed in only 2.9% of registries, indicating a deficiency in data reporting.
Discussion: The incomplete reporting of the full COS poses challenges for physicians and patients in comprehending outcomes and quality of life, making it difficult to make comparisons between different treatments. The limited adherence to the COS is thought to be attributed to the lack of awareness. To address this issue, there is a crucial need to increase awareness and promote the uptake of the COS, ensuring consistent and relevant reporting.
| Original language | American English |
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| State | Published - 21 Jul 2023 |
| Event | 7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics - Tandy Conference Center, Tulsa, United States Duration: 21 Jul 2023 → 21 Jul 2023 |
Conference
| Conference | 7th Annual Joint Research Meeting: Biomedical, Biological, Neuroscience, Physiology, Forensics |
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| Abbreviated title | 7th Joint Annual Research Meeting |
| Country/Territory | United States |
| City | Tulsa |
| Period | 21/07/23 → 21/07/23 |