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Articles by Ethan Basch
Patient-reported outcomes as early indicators of recurrence, disease progression, and survival via machine learning in breast cancer
Abstract Patient-reported outcomes (PROs) offer a non-invasive, low-cost way to capture patients’ symptoms, functioning, and quality of life. Yet, their potential as early indicators of tumor size, recurrence/disease progression, and survival remains unclear. We retrospectively analyzed 445,239 longitudinal PRO entries from 2738 patients with breast cancer, pooled from four clinical trials, including both early- and late-stage disease, covering 15 PRO measures.
Sharing patient-reported outcomes with clinical investigators in real time
Get full text access Log in, subscribe or purchase for full access. References 1. Atkinson, TM ∙ Li, Y ∙ Coffey, CW ∙ et al. Reliability of adverse symptom event reporting by clinicians Qual Life Res. 2012; 21:1159-1164 2. Shrout, PE ∙ Fleiss, JL Intraclass correlations: uses in assessing rater reliability Psychol Bull. 1979; 86:420-428 3. Di Maio, M ∙ Gallo, C ∙ Leighl, NB ∙ et al.
Cancer Care Research in North Carolina: The State of the State
Wheeler, Stephanie B., and Ethan Basch. 2014. "Cancer Care Research in North Carolina: The State of the State." North Carolina Medical Journal 75 (4): 248-52. https://doi.org/10.18043/ncm.75.4.248.
Predictive and Prognostic Significance of Patient‐Reported Outcomes for Survival and Adverse Events in Daratumumab‐Treated Multiple Myeloma
1 Introduction Multiple myeloma (MM) is a hematological malignancy characterized by the proliferation of plasma cells in the bone marrow [1]. Despite advancements in treatment, MM remains incurable, with a 5-year survival rate of around 60% [2], underscoring the need for more effective treatment strategies that improve survival and quality of life. Recent years have witnessed a transformation in MM treatment with the introduction of novel agents such as daratumumab, bortezomib, and lenalidomide.
Promoting Reasonable Career Expectations and Maximizing Professional Fulfillment for Academic Oncologists: ASCO Recommendations for Academic Medical Centers
1 ASCO identified the oncology profession as a focus of its 5-year strategic plan in 2023, with the aim of promoting positive and productive clinical and research environments that maximize professional fulfillment for oncology professionals.2 This goal is similar to the vision outlined in the 2024 National Academy of Medicine's (NAM's) National Plan for Heath Workforce Well-Being that patients are cared for by a health workforce that is thriving in an environment that fosters their...
Symptom monitoring with electronic patient-reported outcomes during cancer treatment: final results of the PRO-TECT cluster-randomized trial - Nature Medicine
Abstract Symptoms are often underdetected during cancer treatment. To determine if symptom monitoring with electronic patient-reported outcomes (PROs) improves clinical outcomes, we conducted a cluster-randomized trial in which 52 oncology practices were assigned to PRO or usual care. At PRO practices, patients with metastatic cancer were invited to complete weekly symptom surveys. Severe or worsening symptoms generated alerts to the care team.
Symptom Monitoring With Patient-Reported Outcomes During Pediatric Cancer Care
Symptom Monitoring With Patient-Reported Outcomes During Pediatric Cancer Care Symptom Screening Linked to Care Pathways for Pediatric Patients With Cancer L. Lee Dupuis, RPh, PhD; Emily Vettese, BASc; Allison C. Grimes, MD, MSCI; Melissa P. Beauchemin, PhD; Lisa M. Klesges, PhD; Christina Baggott, PhD; Jenna Demedis, MD, MS; Catherine Aftandilian, MD; David R. Freyer, DO, MS; Nicole Crellin-Parsons, BSc; Etan Orgel, MD, MS; David Dickens, MD; Kara M.
Benefits of Breast Cancer Screening and Treatment on Mortality
Benefits of Breast Cancer Screening and Treatment on Mortality Analysis of Breast Cancer Mortality in the US—1975 to 2019 Jennifer L. Caswell-Jin, MD; Liyang P. Sun, MSc; Diego Munoz, PhD; Ying Lu, PhD; Yisheng Li, PhD; Hui Huang, MS; John M. Hampton, MSc; Juhee Song, PhD; Jinani Jayasekera, PhD; Clyde Schechter, MD, MA; Oguzhan Alagoz, PhD; Natasha K. Stout, PhD; Amy Trentham-Dietz, PhD; Sandra J. Lee, ScD; Xuelin Huang, PhD; Jeanne S. Mandelblatt, MD, MPH; Donald A. Berry, PhD; Allison W.
An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial | BMC Cancer | Full Text
References American Cancer Society. Cancer Facts & Figures 2021. 2021. https://www.cancer.org/research/cancer-factsstatistics/all-cancer-facts-figures/cancer-facts-figures-2021.html. United Ostomy Associations of America. What is an Ostomy?. https://www.ostomy.org/what-isan-ostomy/. Accessed 3 Jan 2022. Liu L, Herrinton LJ, Hornbrook MC, Wendel CS, Grant M, Krouse RS. Early and late complications among long-term colorectal cancer survivors with ostomy or anastomosis. Dis Colon Rectum. 2010;53(2):200–12.
Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial
Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial | Oncology | JAMA | JAMA Network [Skip to Navigation] Visual Abstract. Electronic Symptom Monitoring With Patient-Reported Surveys and Outcomes Among Patients With Metastatic Cancer Figure 1.
Patient-Reported Outcomes Integrated Within an Electronic Medical Record in Patients With Head and Neck Cancer
Abstract Patient-reported outcome (PRO) tools lead to clinical benefits, including improved overall survival for patients with cancer. However, routine implementation of PROs in clinical practice within the electronic medical record (EMR) by integrated health care delivery systems remains limited. We studied the use of a PRO tool for patients with head and neck cancer (HNC) integrated in an EMR at Kaiser Permanente in Northern California.
Comparison of weekly and daily recall of pain as an endpoint in a randomized phase 3 trial of cabozantinib for metastatic castration-resistant prostate cancer - Elisabeth M Schaffer, Ethan M Basch, Gisela M Schwab, Antonia V Bennett, 2021
Introduction Pain is a common symptom of metastatic cancer that affects physical functioning and quality of life.1–5 Patients with advanced cancer are particularly susceptible to debilitating pain, and identifying agents to control and relieve pain for these patients is a critical research need.3,5 Although pain has often been included as a secondary endpoint in novel drug trials to support investigation of primary survival endpoints, some secondary endpoint analyses have been designed to...
Clinicians may underreport adverse events in phase 1 trials
March 12, 2021 4 min read Save Source/Disclosures Published by: Disclosures: Hansen reports institutional clinical trial funding from and compensated consultant/advisory roles with Astellas Pharma, AstraZeneca/MedImmune, Bayer, Boehringer-Ingelheim, Bristol Myers Squibb, GlaxoSmithKline, Karyopharm Therapeutics, Merck, Novartis, Pfizer and Roche/Genentech. Please see the study for all other authors’ relevant financial disclosures.
Broadened Eligibility for Lung Cancer Screening
Sign in to your personal account Institutional sign in: OpenAthens | Shibboleth Purchase access Buy this article and get unlimited access and a printable PDF ($30.00) - Sign in or create a free account Sign in to download free article PDFs Sign in to your personal account Institutional sign in: OpenAthens | Shibboleth Get free access to newly published articles Create a personal account or sign in to: Register for email alerts with links to free full-text articles Access PDFs of free...
Comparing Clinician-Assessed and Patient-Reported Performance Status for Predicting Morbidity and Mortality in Patients With Advanced Cancer Receiving Chemotherapy | JCO Oncology Practice
PURPOSE: Performance status (PS) is assessed during cancer treatment to determine clinical trial eligibility, appropriateness for treatment, and need for supportive care. There is rising interest for patients to report this information directly. We determined whether clinician- and patient-reported PS were equally associated with mortality and service utilization in patients with cancer.
Composite grading algorithm for the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) - Ethan Basch, Claus Becker, Lauren J Rogak, Deborah Schrag, Bryce B Reeve, Patricia Spears
Article Information Article first published online: December 1, 2020 Ethan Basch1, 2, Claus Becker3, Lauren J Rogak2, Deborah Schrag4, Bryce B Reeve5, Patricia Spears1, Mary Lou Smith6, Mrinal M Gounder2, Michelle R Mahoney7, Gary K Schwartz8, Antonia V Bennett1, Tito R Mendoza9, Charles S Cleeland9, Jeff A Sloan7, Deborah Watkins Bruner10, Gisela Schwab11, Thomas M Atkinson2, Gita Thanarajasingam12, Monica M Bertagnolli13, Amylou C Dueck14 1UNC Lineberger Comprehensive Cancer Center,...
Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials: findings from an international, multidisciplinary working group
1. A systematic review of the impact of routine collection of patient reported outcome measures on patients, providers and health organisations in an oncologic setting. BMC Health Serv Res. 2013; 13: 211 2. US Department of Health and Human Services FDA Center for Drug Evaluation and Research Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006; 4: 79 3.
Clinical Utility and User Perceptions of a Digital System for Electronic Patient-Reported Symptom Monitoring During Routine Cancer Care: Findings From the PRO-TECT Trial | JCO Clinical Cancer Informatics
1. Panattoni L, Fedorenko C, Greenwood-Hickman MA, et al: Characterizing potentially preventable cancer- and chronic disease-related emergency department use in the year after treatment initiation: A regional study. J Oncol Pract 14:e176-e185, 2018 Link, Google Scholar 2. Henry DH, Viswanathan HN, Elkin EP, et al: Symptoms and treatment burden associated with cancer treatment: Results from a cross-sectional national survey in the US.
Clinical Utility and User Perceptions of a Digital System for Electronic Patient-Reported Symptom Monitoring During Routine Cancer Care: Findings From the PRO-TECT Trial | JCO Clinical Cancer Informatics
Symptoms are commonly experienced among patients receiving cancer treatment and are a major cause of distress, functional disability, and emergency room/hospital utilization1,2 but go undetected and unaddressed by clinicians up to half the time.3-7 There is substantial interest in using digital strategies to systematically monitor patients’ symptoms in real-world clinical settings to catch problems early before they worsen or cause complications.8-10 CONTEXT Key Objective What are the...
Antiemetics: ASCO Guideline Update
The goals of this update are to provide oncologists, other health care practitioners, patients, and caregivers recommendations on the use of dexamethasone as a prophylactic antiemetic in patients receiving checkpoint inhibitors and information on new antiemetics, antiemetic regimens, and anticancer agent emetogenicity.
Financial Relationships With Industry Among National Comprehensive Cancer Network Guideline Authors
doi: 10.1001/jamaoncol.2016.2710. Aaron P Mitchell 1 , Ethan M Basch 1 , Stacie B Dusetzina 2 Affiliations Affiliations 1 Department of Hematology/Oncology, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill2Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill.
Congruence of patient‐ and clinician‐reported toxicity in women receiving chemotherapy for early breast cancer
Original Article Kirsten A. Nyrop PhD Corresponding Author E-mail address: kirsten_nyrop@med.unc.edu https://orcid.org/0000-0001-5320-1357 School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina Corresponding Author: Kirsten A.
Electronic Patient-Reported Outcomes as Digital Therapeutics to Improve Cancer Outcomes
Among patients receiving treatment for advanced cancers, symptoms are common and frequently cause distress, functional impairment, and emergency room visits.1 Yet cancer patients’ symptoms often go undetected and unaddressed by clinicians.2-4 There is growing international interest in integrating electronic patient-reported outcomes (PROs) into routine practice as digital therapeutics that can increase detection and inform management of symptoms, thereby improving health outcomes and patient...
ASCO’s Quality Care Symposium and the Evolving Science of Value-Based Care
Since 2012, ASCO has sponsored its annual Quality Care Symposium. In developing this symposium, ASCO recognized the emerging importance of quality improvement and measurement in clinical practice and the value to the oncology community of a forum for sharing ideas and experiences.
Adding Patient-Reported Outcomes to Medicare’s Oncology Value-Based Payment Model
On November 1, 2019, the Centers for Medicare & Medicaid Services (CMS) Innovation Center released details of a proposed alternative payment model for medical oncology care, called Oncology Care First (OCF), for public comment.1 The OCF model will succeed the Oncology Care Model (OCM), which will expire at the end of 2020. When it started in 2016, the OCM, which was voluntary, was important in oncology due to its emphasis on value-based care transformation.
Patients' Responsibility to Participate in Decision Making and Research
Patient-centered care is defined by the Institute of Medicine as care that is respectful of patient preferences and in which patient values guide clinical decisions.1 Patient-centered care is not possible without patients and their caregivers playing a central role in care decisions and, importantly, in the research that informs those decisions.
Association of Community Cancer Centers announces award recipients
The Association of Community Cancer Centers will present awards to three oncology professionals at its 36th National Oncology Conference, which will be held Oct. 30 to Nov. 1 in Orlando. Ethan Basch, MD, MSc, director of the cancer outcomes research program at UNC Lineberger Comprehensive Cancer Center and professor in the division of hematology and oncology at UNC School of Medicine, will receive the Clinical Research Award.
Harnessing the patient voice in real-world evidence: the essential role of patient-reported outcomes
COMMENT 15 May 2019 Real-world evidence is increasingly valued by regulators and payers. Central to this evidence base is patient-reported outcome data describing the impact of drugs on quality of life, daily activities and symptoms. Here, we highlight key challenges with current real-world, patient-reported outcome data and describe collaborative next steps for international stakeholders to overcome these issues. Melanie J.
The Evolving Uses of “Real-World” Data
[Skip to Content Landing] Original Investigation Association of Patient Characteristics and Tumor Genomics With Non–Small Cell Lung Cancer Outcomes Gaurav Singal, MD; Peter G. Miller, MD, PhD; Vineeta Agarwala, MD, PhD; Gerald Li, PhD; Gaurav Kaushik, PhD; Daniel Backenroth, PhD; Anala Gossai, PhD, MPH; Garrett M. Frampton, PhD; Aracelis Z. Torres, PhD, MPH; Erik M.
Cost-Effectiveness of Web-Based Patient-Reported Outcome Surveillance in Patients With Lung Cancer
Introduction After initial treatment for localized or advanced lung cancers, patients are generally followed for recurrence or progression via surveillance consisting of serial imaging and consultations with oncologists. The modalities and frequencies of these activities are not evidence-based, and are generally derived from consensus recommendations of professional societies.1x1Colt, H.G., Murgu, S.D., Korst, R.J., Slatore, C.G., Unger, M., and Quadrelli, S.
Patient-reported outcome monitoring in a routine paediatric oncology setting: challenges and opportunities
Cancer affects one in every 500 children younger than 15 years in the UK, and around 1800 new cases are diagnosed in this population every year. 1 Despite advances in treatments and improved overall survival, children with cancer have a high symptom burden, related both to the underlying cancer and associated treatments that can substantially affect their physical, mental, social, and emotional wellbeing, and cognitive function.
Cabozantinib Versus Mitoxantrone-prednisone in Symptomatic Metastatic Castration-resistant Prostate Cancer: A Randomized Phase 3 Trial with a Primary Pain Endpoint
1. Introduction Most prostate cancer-specific deaths occur in patients with metastatic castration-resistant prostate cancer (mCRPC), frequently preceded by debilitating pain and functional compromise [1x[1]Halabi, S., Vogelzang, N.J., Kornblith, A.B. et al. Pain predicts overall survival in men with metastatic castration-refractory prostate cancer. J Clin Oncol. 2008; 26: 2544–2549 Google ScholarSee all References][1].
Collection of patient-reported outcomes crucial for improving care
Receive an email when new articles are posted on this topic . Please provide your email address to receive an email when new articles are posted on this topic . The implementation of a simple technology to collect and store patient-reported outcomes could improve patients’ quality of life and outcomes and enhance patient–provider communication, according to Ethan Basch, MD, MSc, director of UNC Lineberger Cancer Outcomes Research program.
Effect of apalutamide on health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the SPARTAN randomised, placebo-controlled, phase 3 trial
In the SPARTAN trial, addition of apalutamide to androgen deprivation therapy, as compared with placebo plus androgen deprivation therapy, significantly improved metastasis-free survival in men with non-metastatic castration-resistant prostate cancer who were at high risk for development of metastases. We aimed to investigate the effects of apalutamide versus placebo added to androgen deprivation therapy on health-related quality of life (HRQOL).
Statistical analysis of patient-reported outcome data in randomised controlled trials of locally advanced and metastatic breast cancer: a systematic review
Although patient-reported outcomes (PROs), such as health-related quality of life, are important endpoints in randomised controlled trials (RCTs), there is little consensus about the analysis, interpretation, and reporting of these data. We did a systematic review to assess the variability, quality, and standards of PRO data analyses in advanced breast cancer RCTs. We searched PubMed for English language articles published in peer-reviewed journals between Jan 1, 2001, and Oct 30, 2017.
Optimizing Anticancer Therapy in Metastatic Non-Castrate Prostate Cancer: American Society of Clinical Oncology Clinical Practice Guideline
Three prospective randomized studies (GETUG-AFU 15, STAMPEDE, and CHAARTED) examined overall survival (OS) with adding docetaxel to ADT. STAMPEDE and CHAARTED favored docetaxel (hazard ratio [HR], 0.78; 95% CI, 0.66 to 0.93; n = 2,962 and HR, 0.73; 95% CI, 0.59 to 0.89; n = 790, respectively). GETUG-AFU 15 was negative. LATITUDE and STAMPEDE examined the impact on OS of adding abiraterone (with prednisone or prednisolone) to ADT.
Patient-reported outcomes: an essential component of oncology drug development and regulatory review
Patient-Reported Symptom Monitoring During Chemotherapy-Reply
In Reply In response to the query by Dr Douma and colleagues regarding the HR of 0.83 reported in the multivariable analysis of overall survival, the clinical meaningfulness bar of an HR of 0.8 suggested by working groups of the ASCO Cancer Research Committee is intended for application to a different context, namely clinical trials of costly and toxic antineoplastic therapies.1 Although there is some cost associated with infrastructure and staffing for an online symptom-reporting...
Role of Patient-Reported Outcomes in Postsurgical Monitoring in Oncology
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Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment
[Skip to Navigation] Figure. Overall Survival Among Patients With Metastatic Cancer Assigned to Electronic Patient-Reported Symptom Monitoring During Routine Chemotherapy vs Usual Care Crosses indicate censored observations.
Evaluating Alternative Payment Models in Oncology
Cancer care is expensive, and like other chronic illnesses, is prone to waste both through overuse of low-value services and underuse of evidence-based approaches.1 The fee-for-service model has been cited as a major factor, creating perverse incentives to provide high-cost, low-value care without sufficiently monitoring quality.2 Alternative models have been proposed as a means to both control costs and improve quality in oncology, including accountable care organizations, bundled...
Feasibility Assessment of Patient Reporting of Symptomatic Adverse Events in Multicenter Cancer Clinical Trials
Question Is it feasible to collect patient-reported symptomatic adverse events in large multicenter oncology clinical trials? Findings Among 285 patients enrolled in 9 US multicenter cancer treatment trials, symptomatic adverse events were successfully self-reported by paients at 93.9% of expected times. Most patients believed that the system was easy to use and useful, and investigators thought that the patient-reported adverse event data were useful and accurate.
All together now: findings from a PCORI workshop to align patient-reported outcomes in the electronic health record
In recent years, patient-reported outcomes have become increasingly collected and integrated into electronic health records. However, there are few cross-cutting recommendations and limited guidance available in this rapidly developing research area.
It’s a long shot, but it just might work! Perspectives on the future of medicine
What was the last product you searched for online? Every aspect of the information presented to you, from its position on the screen to whether the text was underlined, was shaped by thousands of online randomized controlled experiments and scads of data being processed in real-time from millions of other customers like you [1]. Contrast this experience with the last time you received a healthcare intervention.
Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review: Perspectives From Industry, the Food and Drug Administration, and the Patient | Jun 01, 2015 | JAMA Oncology | JAMA Network
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Time to Reassess the Cancer Compendia for Off-label Drug Coverage in Oncology
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Reply to K. Kroenke et al
We thank Kroenke and Cheville1 for their thoughtful letter and appreciate their endorsement of our study and findings. We agree with them that, in our study,2 patient reporting of symptoms was not the sole driver of improved clinical outcomes. As we describe in the article, our intervention was a composite that also included automated e-mail alerts to clinicians for severe or worsening patient-reported symptoms and printed symptom reports at visits.
The Rise of Patient-Reported Outcomes in Oncology
Just a few years ago, few had heard of the term “patient-reported outcome” or “PRO.” Now, PROs seem to come up frequently in discussions about almost every aspect of oncology—in clinical care delivery, clinical trials, quality assessment, and comparative effectiveness research (Fig. 1 shows uses and benefits of PROs in each of these contexts). PROs are reflections of how patients feel and function—for example, symptoms related to disease or toxicities, physical functioning, or quality of life.
Patient-reported outcomes must play critical role in oncology value frameworks
May 25, 2016 2 min read ADD TOPIC TO EMAIL ALERTS Receive an email when new articles are posted on Please provide your email address to receive an email when new articles are posted on . We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. When I sit down with a patient to discuss starting a new cancer treatment, one of the first questions I am asked is how that treatment will make the patient feel.
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