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Articles by David Cella
A multi-dimensional framework for predicting taxane-induced peripheral neuropathy in Black women with breast cancer: findings from ECOG-ACRIN EAZ171
Abstract Taxane-induced peripheral neuropathy (TIPN) is a critical drug-related toxicity impacting many breast cancer patients. EAZ171 previously found that for patients of Black race, every three-week docetaxel had less TIPN compared with weekly paclitaxel. Here we set out to determine whether clinical, social, and genetic variables could further refine the risk in EAZ171.
Stakeholder perspectives on potential open-label bias in patient-reported outcome results from cancer clinical trials: evidence from the IMPROvE project
Affiliations & Notes 1Italian Group for Adult Hematologic Diseases (GIMEMA), Data Center and Health Outcomes Research Unit, Rome, Italy 2University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria 3Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, the Netherlands 4Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA 5Department of Applied Health Sciences, School of...
Symptoms and subtypes of patients with lower urinary tract dysfunction — insights from the Symptoms of Lower Urinary Tract Dysfunction Research Network
Abstract Lower urinary tract dysfunction presents with a wide range of bothersome urinary symptoms, which are common in both men and women, with incidence and prevalence increasing with age. Individuals with lower urinary tract symptoms (LUTS) suffer from the chronicity of their symptoms, have a reduced quality of life, and experience high morbidity with associated medical conditions. Various treatment options exist, but many patients do not find satisfactory or lasting relief.
Patient-Reported Outcome Measures in Clinical Trials: An Analysis of Trends from 2008-2023
Precis: PRO measure use in interventional trials doubled from 2008-2023, with EQ-5D becoming the leading generic measure and PROMIS showing fastest growth. Authorship Contribution: All authors certify that they meet the ICMJE criteria for authorship. Funding Source: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Correction: Cross-sectional validation of the PROMIS-Preference scoring system
After publication of this article [1], it was noted that the data in the Dataverse link in the Data Availability statement is deaccessioned. The dataset found previously at https://dataverse.harvard.edu/dataset.xhtml?persistentId=doi:10.7910/DVN/P7UKWR can now be found at https://dataverse.harvard.edu/dataset.xhtml?persistentId=doi:10.7910/DVN/VVNWJX.
An alternative perspective on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 item Scale (FACIT-Sp-12) in people newly diagnosed with advanced cancer
Abstract Purpose Information is lacking regarding how patients interpret the term spiritual. Consequently, for questions containing the word spiritual, such as in the Functional Assessment of Chronic Illness Therapy–Spiritual Well-Being 12 item Scale (FACIT-Sp-12), it is unclear whether patients are responding to religious or non-religious spirituality.
Patient Report May Understate Walking Disability in Peripheral Artery Disease
Patient Report May Understate Walking Disability in Peripheral Artery Disease Lower extremity peripheral artery disease (PAD) affects 10% to 15% of people 65 years or older and is underdiagnosed and undertreated. PAD is characterized by atherosclerotic blockages of lower extremity arteries that impair oxygen delivery to lower extremity skeletal muscle, limiting walking speed and endurance.
Self-affirmation intervention for patients newly diagnosed with advanced cancer: a preliminary efficacy trial
Abstract Objective Cancer diagnosis represents a life crisis. It remains unclear whether/what psychosocial intervention may enhance cancer patients’ quality of life (QoL) during existential plight. This study aimed to examine preliminary efficacy of a brief writing intervention for patients newly diagnosed with advanced cancer with a focus on affirming personally important values and beliefs.
ECOG-ACRIN EAZ171: Prospective Validation Trial of Germline Predictors of Taxane-Induced Peripheral Neuropathy in Black Women With Early-Stage Breast Cancer
The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.
Efficient measurement of multiple ventricular assist device patient-reported outcomes: Creation of a 20-item profile from the MCS A-QOL study
KEYWORDS mechanical circulatory support left ventricular assist device patient-reported outcomes health-related quality of life adjustment Get full text access Log in, subscribe or purchase for full access. References 1. Cella, D. ∙ Hahn, E.A. ∙ Jensen, S.E. ... Patient-Reported Outcomes in Performance Measurement.RTI Press, Research Triangle Park (NC), 2015 Publication No.: RTI-BK-0014-1509. ISBN-13: 978-1-934831-14-4 2.
Fatigue in newly diagnosed acute myeloid leukaemia: general population comparison and predictive factors
Abstract Objectives This study compared the burden of fatigue between treatment-naïve patients with newly diagnosed acute myeloid leukaemia (AML) and the general population and investigated patient factors associated with fatigue severity. Methods Pretreatment patient-reported fatigue was assessed with the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire in a sample of 463 newly diagnosed patients with AML who were enrolled in a clinical trial.
Health-Related Quality of Life With Nivolumab Plus Chemotherapy Versus Chemotherapy in Patients With Advanced Gastric/Gastroesophageal Junction Cancer or Esophageal Adenocarcinoma From CheckMate 649 | Journal of Clinical Oncology
Gastric/gastroesophageal junction cancer (GC/GEJC) and esophageal adenocarcinoma (EAC) are among the leading causes of global cancer-related mortality.1 Strong similarities in molecular profiles between GC/GEJC and EAC suggest that these cancers could be considered a single disease entity.2,3 Chemotherapy, the standard first-line treatment for patients with unresectable advanced or metastatic human epidermal growth factor receptor 2 (HER2)–negative GC/GEJC, has been associated with poor...
The Estimand Framework had Implications in Time to Patient-Reported Outcomes Deterioration Analyses in Cancer Clinical Trials
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Understanding the patient experience and treatment benefits in patients with non-small‐cell lung cancer with brain metastasis
Study design This qualitative research project was conducted in a stepwise approach consistent with regulatory recommendations.23 The first step was to conduct a targeted literature review to identify the symptoms and impacts reported by patients who had been diagnosed with BM and to determine whether any previously developed patient-reported instrument adequately assessed these concepts.
Nivolumab plus cabozantinib for advanced renal cell carcinoma
Papers of special note have been highlighted as: • of interest; • • of considerable interest • None Phase I study of cabozantinib and nivolumab alone or with ipilimumab for advanced or metastatic urothelial carcinoma and other genitourinary tumors . 38(31), 3672–3684 ( ). • A pertinent reference given that the phase I data provided the basis for combining cabozantinib and nivolumab in treating advanced RCCMedline, CAS 38(31), 3672–3684 ().
CheckMate 214: A Deep Dive into Ipilimumab and Nivolumab for Advanced Renal Cell Carcinoma - David Cella
Read the Full Video Transcript Pedro Barata: Hi, I'm Pedro Barata. I'm a GU medical oncologist at Tulane Medical School in New Orleans, Louisiana. It's a privilege to have here with me today Dr. David Cella. He's a PhD and Professor and Chair of the Department of Medical Social Sciences at Northwestern University and Feinberg School of Medicine in Chicago. Welcome, Dr. Cella. David Cella: Thank you, Dr. Barata.
Integration of Palliative and Supportive Care Into the Management of Genitourinary Malignancies
For more than a decade, advocates have urged integration of palliative and supportive care into routine oncologic care to optimize patient-centered care. Several areas of genitourinary cancer are ripe for integration of palliative and supportive care: for example, including the geriatric assessment in patient decision-making.
Patient-reported outcomes: what really matters to patients? - Authors' reply
The International Kidney Cancer Coalition , representing 1·2 million patients with kidney cancer globally, and its medical advisory board commend the comprehensive analysis by David Cella and colleagues1 of patient-reported outcomes (PROs) and quality of life (QOL) among patients diagnosed with metastatic renal cell carcinoma that was published in The Lancet Oncology. However, the patient community would like to raise a few additional points of discussion.
Patient-reported outcomes with first-line nivolumab plus cabozantinib versus sunitinib in patients with advanced renal cell carcinoma treated in CheckMate 9ER: an open-label, randomised, phase 3 trial
Summary Background In the CheckMate 9ER trial, patients with advanced renal cell carcinoma who received first-line nivolumab plus cabozantinib had significantly better progression-free survival compared with those given sunitinib. In this study, we aimed to describe the patient-reported outcome (PRO) results from CheckMate 9ER.
Early Local Therapy for the Primary Site in De Novo Stage IV Breast Cancer: Results of a Randomized Clinical Trial (EA2108)
Abstract Distant metastases are present in 6% or more of patients with newly diagnosed breast cancer. In this context, locoregional therapy for the intact primary tumor has been hypothesized to improve overall survival (OS), but clinical trials have reported conflicting results.
Early Local Therapy for the Primary Site in De Novo Stage IV Breast Cancer: Results of a Randomized Clinical Trial (E2108)
Article Tools ORIGINAL REPORTS Breast Cancer Abstract Full Text PDF Figures and Tables Supplements Abstract Distant metastases are present in 6% or more of patients with newly diagnosed breast cancer. In this context, locoregional therapy for the intact primary tumor has been hypothesized to improve overall survival (OS), but clinical trials have reported conflicting results.
Quality-of-life methodology in hormone receptor-positive advanced breast cancer: current tools and perspectives for the future
Highlights • Systematic literature review of HRQOL assessment–HR+ advanced breast cancer trials. • No clear standard for PROM use, reporting, and analysis were observed. • Common PROMs in the analysis included the EORTC QLQ-C30 and FACT-B. • CDK4/6 inhibitors (CDK4/6i) were the most common agents in the analysis. • CDK4/6i improved or maintained most PROM scores vs placebo, with some exceptions.
Turkish validation and reliability of the symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index‐29 (LURN SI‐29) questionnaire in patients with lower urinary tract symptoms
CLINICAL ARTICLE Meftun Culpan, Corresponding Author mculpan@gmail.com orcid.org/0000-0001-8573-1192 Department of Urology, Faculty of Medicine, Istanbul Medeniyet University, Istanbul, Turkey Correspondence Meftun Culpan, Department of Urology, Faculty of Medicine, Istanbul Medeniyet University, Eğitim Mah. Dr. Erkin Cad. Kadıköy, İstanbul 34722, Turkey. Email: mculpan@gmail.com Search for more papers by this author Hazal C.
Meaningful change thresholds for Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue and pain interference scores in patients with rheumatoid arthritis
Meaningful change thresholds for Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue and pain interference scores in patients with rheumatoid arthritis Jennifer L. Beaumont, Elizabeth S. Davis, James F. Fries, Jeffrey R. Curtis, David Cella, Huifeng Yun The Journal of Rheumatology Mar 2021, jrheum.200990; DOI: 10.3899/jrheum.200990
Health‐related quality‐of‐life assessment of patients with solid tumors on immuno‐oncology therapies
Review Article Aaron R. Hansen MBBS (Hons) Corresponding Author aaron.hansen@uhn.ca orcid.org/0000-0002-2363-8707 Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada Department of Medicine, Division of Medical Oncology and Hematology, University of Toronto, Toronto, Ontario, Canada Corresponding Author: Aaron R.
The IPSS-R more accurately captures fatigue severity of newly diagnosed patients with myelodysplastic syndromes compared with the IPSS index
Abstract We aimed to compare fatigue of newly diagnosed patients with myelodysplastic syndromes (MDS) with that of the general population (GP). We also investigated the ability of the IPSS and IPSS-R to capture severity of patient-reported fatigue at diagnostic workup. A sample of 927 newly diagnosed patients with MDS was consecutively enrolled in a large international observational study and all patients completed the FACIT-Fatigue questionnaire at baseline.
A new outcome measure for LUTS: Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index‐29 (LURN SI‐29) questionnaire - Cella - - Neurourology and Urodynamics - Wiley Online Library
The full text of this article hosted at iucr.org is unavailable due to technical difficulties.
Evaluation of responsiveness and estimation of smallest detectable change (SDC) and minimal important change (MIC) scores for the Childhood Atopic Dermatitis Impact Scale - Gabes - - British Journal of Dermatology - Wiley Online Library
The full text of this article hosted at iucr.org is unavailable due to technical difficulties. Original Article Evaluation of responsiveness and estimation of smallest detectable change (SDC) and minimal important change (MIC) scores for the Childhood Atopic Dermatitis Impact Scale Christian J.
Patient-reported outcomes of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): a randomised, phase 3 trial
Summary In the ongoing phase 3, CheckMate 214 trial, nivolumab plus ipilimumab improved overall survival compared with sunitinib in patients with intermediate or poor risk, previously untreated, advanced renal cell carcinoma. We aimed to assess whether health-related quality of life (HRQoL) could be used to further describe the benefit-risk profile of nivolumab plus ipilimumab versus sunitinib.
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).
Archives of Physical Medicine and Rehabilitation, September 2018, Volume 99, Issue 9, Pages A1-A18, 1699-1940
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Patient-reported outcomes with nivolumab in advanced solid cancers
Publication HistoryPublished online: August 02, 2018Accepted: August 1, 2018; Received in revised form: July 30, 2018; Received: February 26, 2018;
Quality of Life Outcomes for Cabozantinib Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma: METEOR Phase III Randomized Trial
In the phase III METEOR trial (ClinicalTrials.gov identifier: NCT01865747), 658 previously treated patients with advanced renal cell carcinoma were randomly assigned 1:1 to receive cabozantinib or everolimus. The cabozantinib arm had improved progression-free survival, overall survival, and objective response rate compared with everolimus. Changes in quality of life (QoL), an exploratory end point, are reported here.
PROMIS®-29 v2.0 Profile Physical and Mental Health Summary Scores
Qual Life Res. Author manuscript; available in PMC 2019 Jul 1. Published in final edited form as: PMCID: PMC5999556 NIHMSID: NIHMS953774 Ron D. Hays Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at UCLA, 911 Broxton Avenue, Los Angeles, CA 90095, 310-794-2294; 310-794-0732 FAX Karen L.
A PROMIS Measure of Neuropathic Pain Quality
To view the full text, please login as a subscribed user or purchase a subscription . Click here to view the full text on ScienceDirect. Neuropathic pain (NP) is a consequence of many chronic conditions. This study aimed to develop an unidimensional NP scale with scores that represent levels of NP and distinguish between individuals with NP and non-NP conditions.
Progression-free survival, patient-reported outcomes, and the Holy Grail
In oncology clinical trials, overall survival (OS) remains the gold standard for clinical benefit. However, because there are so many available treatment options for most types of cancer, survival analysis in clinical trials is often confounded by subsequent therapies. Progression-free survival (PFS) is an endpoint not so confounded, and one that requires fewer patients and less time to arrive at a conclusion about a new therapy.
Dose Escalation in Stage III Non-Small-Cell Lung Cancer: Patients Agree With the Clinical Results
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.
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