Objectives: Oncology clinical trials use a variety of clinical endpoints. Patients' understanding of the differences between clinical endpoints is important because misperceptions of treatment efficacy may affect treatment decisions. The objective of this literature review is to find and synthesize available empirical publications assessing patients' understanding of common oncology clinical endpoints.
Methods: We conducted a literature search of 5 databases and 3 conferences, limiting the search to articles and abstracts published in English through September 2018. We reviewed the titles and abstracts for inclusion, then reviewed full texts to determine if they reported empirical research studies focused on (1) clinical endpoints, (2) oncology, and (3) patient understanding. The original search identified 497publications, of which 13 met the inclusion criteria.
Results: Available literature yields little information on this topic.The few publications that do exist suggest that healthcare professionals and cancer patients generally do not discuss clinical endpoint concepts and that patients can be confused about the purpose of a treatment based on misperceptions about endpoints.
Conclusions: Research is needed on how to discuss oncology clinical endpoints with patients.
Practice Implications: Patient-friendly definitions of clinical endpoints may help healthcare providers communicate important information about treatments to patients.
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http://dx.doi.org/10.1016/j.pec.2020.03.018 | DOI Listing |
EClinicalMedicine
October 2024
Department of Oncology, Queen's University, Kingston, Canada.
Patients with cancer expect prolonged life (overall survival, OS) or better life (quality of life, QOL) from cancer treatments. However, majority of new cancer drugs are now being approved not based on improved OS or QOL, but based on surrogate endpoints such as tumor shrinkage or delayed tumor progression. These surrogate endpoints, including their validity as a proxy for overall survival, differ based on disease settings and lines of treatment but in general, most surrogate measures have weak correlation with outcomes that matter to patients.
View Article and Find Full Text PDFFront Med (Lausanne)
December 2024
Rheumatology Unit, Department of Medicine-DIMED, University - Padova University Hospital, Padua, Italy.
Objectives: This pilot study aimed to identify early predictors of drug retention in patients with clinically active peripheral psoriatic arthritis who initiated or switched to therapy with biologic and targeted synthetic disease-modifying antirheumatic drugs (bDMARDs and tsDMARDs).
Methods: Clinical and ultrasound assessments were conducted at baseline (t0) and subsequently at 1 (t1), 3 (t3), and 6 (t6) months. Ultrasound evaluations targeted joints/entheses according to PsASon-Score13 and the most clinically involved joint/enthesis/tendon or the two most clinically involved joints/entheses/tendons (MIJET and 2MIJET).
EClinicalMedicine
December 2024
Department of Neurology, Brain Research Institute, Niigata University, Niigata, Japan.
Background: Therapeutic advancements for the polyglutamine diseases, particularly spinocerebellar degeneration, are eagerly awaited. We evaluated the safety, tolerability, and therapeutic effects of L-arginine, which inhibits the conformational change and aggregation of polyglutamine proteins, in patients with spinocerebellar ataxia type 6 (SCA6).
Methods: A multicenter, randomized, double-blind, placebo-controlled phase 2 trial (clinical trial ID: AJA030-002, registration number: jRCT2031200135) was performed on 40 genetically confirmed SCA6 patients enrolled between September 1, 2020, and September 30, 2021.
Front Neurosci
December 2024
The Neuro's Early Drug Discovery Unit (EDDU), McGill University, Montreal, QC, Canada.
This study aimed to evaluate different combinations of three dietary supplements for potential additive or synergistic effects in an Parkinson's Disease model. The complex and diverse processes leading to neurodegeneration in each patient with a neurodegenerative disorder cannot be effectively addressed by a single medication. Instead, various combinations of potentially neuroprotective agents targeting different disease mechanisms simultaneously may show improved additive or synergistic efficacy in slowing the disease progression and allowing the agents to be utilized at lower doses to minimize side effects.
View Article and Find Full Text PDFFront Endocrinol (Lausanne)
January 2025
Department of Cardiovascular Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.
Introduction: The Sequential Organ Failure Assessment (SOFA) score is a widely utilized clinical tool for evaluating the severity of organ failure in critically ill patients and assessing their condition and prognosis in the intensive care unit (ICU). Research has demonstrated that higher SOFA scores are associated with poorer outcomes in these patients. However, the predictive value of the SOFA score for acute kidney injury (AKI), a common complication of diabetic ketoacidosis (DKA), remains uncertain.
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