David Cella

David Cella
Northwestern University | NU · Department of Medical Social Sciences

PhD

About

1,025
Publications
208,540
Reads
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107,426
Citations
Additional affiliations
June 2009 - present
Northwestern University
Position
  • Professor (Full)

Publications

Publications (1,025)
Article
Full-text available
Background To evaluate the measurement properties (e.g. content validity, reliability and ability to detect change) of the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale in patients with active psoriatic arthritis (PsA). Methods One-on-one semi-structured qualitative interviews with adult patients with active PsA evaluated...
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Purpose The recent increase in emerging novel therapies in the bladder cancer therapeutic area has increased the need for fit-for-purpose patient-reported outcome (PRO) measures for these patients. This study evaluates the psychometric properties of the Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) in 182 patients with advanced urotheli...
Article
Background: 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 pr...
Article
Background The Functional Assessment of Cancer Therapy–Prostate (FACT‐P) and the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy–Prostate Symptom Index‐17 (NFPSI‐17) are 2 commonly used measures for patient‐reported outcomes in prostate cancer trials. Their use may be enhanced by a better understanding of how change sc...
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Background The Quality of Life in Neurological Disorders (Neuro-QoL) item banks evaluate and monitor the physical, mental, and social health of individuals with neurological conditions. Neuro-QoL items can be administered via short form or computerized adaptive testing. This paper describes the English-to-Simplified Chinese translation of 299 items...
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Introduction Depressive symptoms in patients with intracerebral hemorrhage (ICH) are common and are associated with worse outcomes. It is not well described how often depressive symptoms are ascertained and treated in large unselected cohorts of patients, and whether depressive symptoms would be a potential target for improving outcomes. Methods D...
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Background: The Physical Function Trial (PFT) was one of seven Testosterone Trials (TTrials), the aim of which was to assess the effect of testosterone on mobility, self-reported physical function, falls, and patient global impression-of-change (PGIC) in older men with low testosterone concentrations, self-reported mobility limitation, and walking...
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To evaluate association of carcinoid syndrome (CS) symptom burden and somatostatin analog (SSA) duration with quality of life (QoL) using Functional Assessment of Cancer Therapy-General (FACT-G) and Patient-Reported Outcomes Measurement Information System (PROMIS-29) instruments.Adults who received treatment for CS symptoms in the US were recruited...
Article
Objective: To compare, by collection time and patient characteristics, inpatient rehabilitation quality measure scores calculated using patient-reported data. Design: Cohort study of rehabilitation inpatients with neurologic conditions who reported their experience of care and pain status at discharge and 1month after discharge. Setting: Two i...
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Purpose: Patients with metastatic neuroendocrine tumors and carcinoid syndrome (CS) may experience chronic, recurring symptoms despite somatostatin analogue therapy. Little is known about the relationship between bowel movement (BM) frequency, patient-reported symptoms and health-related quality of life (QoL). Data from the TELESTAR study were use...
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Disruptive behavior in childhood is common. It spans from normative child misbehaviors to clinically-significant and impairing problems. While there are many rating scales evaluating such behaviors, historically, measurement has emphasized counting the number of symptoms present rather than assessing the normal-abnormal spectrum of behavioral expre...
Article
Objective: To develop a new measurement system, the TBI-CareQOL, that can evaluate both general and caregiving-specific aspects of health-related quality of life (HRQOL) in caregivers of persons with traumatic brain injury (TBI). Design: New item pools were developed and refined using literature reviews, qualitative data from focus groups, and c...
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Background Itch is common and often debilitating. Itch is best assessed by self-report, often using patient-reported outcome measures (PROMs). Current PROMs for itch are limited and may not capture its full impact on quality of life (QOL). Objective We sought to develop a comprehensive conceptual model of itch to improve the understanding of itch...
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Objectives The PROMIS-Preference (PROPr) score is a recently developed summary score for the Patient-Reported Outcomes Measurement Information System (PROMIS). PROPr is a preference-based scoring system for seven PROMIS domains created using multiplicative multi-attribute utility theory. It serves as a generic, societal, preference-based summary sc...
Data
Covert scene configuration memory test and stimuli example. (A) Example study block (top) and test block trials (bottom). During the test portion of this task, participants viewed a series of 12 scenes for 8 seconds and were asked to rate how well they thought they learned that scene; ISIs were randomized between scenes. During the test portion, pa...
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Purpose Patients with advanced cancer (ACPs) participating in phase I clinical trials inadequately understand many elements of informed consent (IC); however, the prevalence and impact of cognitive impairment has not been described. Patients and Methods ACPs enrolled onto phase I trials underwent neuropsychological assessment to evaluate cognitive...
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Background: Limited information is available on the performance characteristics of 2 questionnaires commonly used in clinical research, the Psychosexual Daily Questionnaire (PDQ) and the Derogatis Interview for Sexual Function (DISF)-II Assessment, especially in older men with low testosterone (T) and impaired sexual function. Aim: To determine...
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Nearly three out of four survivors experience Cancer-Related Cognitive Impairment (CRCI) for months or years following treatment. Both clinical and animal studies point to the hippocampus as a likely brain region affected in CRCI, however no previous study has investigated the functional connectivity of the hippocampus in CRCI. We compared hippocam...
Article
Objective: To examine the reliability and validity of the short form (SF) and computer adaptive test (CAT) versions of the Patient Reported Outcomes Measurement Information System (PROMIS) measures of social health of caregivers of civilians and service members/veterans (SMVs) with traumatic brain injury (TBI). Design: Self-report questionnaires...
Article
Background: Health-related quality of life (HRQL) preference-based scores are used to assess the health of populations and patients and for cost-effectiveness analyses. The National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS®) consists of patient-reported outcome measures developed using item response the...
Article
Purpose: The Patient-Reported Outcomes Measurement Information System (PROMIS) is a National Institutes of Health initiative designed to improve patient-reported outcomes using state-of-the-art psychometric methods. The aim of this study is to describe qualitative efforts to identify and refine items from psychological well-being subdomains for fu...
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Introduction: A critical challenge in oncology is interpreting clinical trial results to inform clinical decision making. Clinical trials typically focus on overall survival (OS) and progression-free survival (PFS) as primary end points, which do not reflect early signs of meaningful patient benefit or harm. Cancer symptom response (CSR) can provid...
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Objective: To examine the reliability and validity of Patient Reported Outcomes Measurement Information System (PROMIS) measures of sleep disturbance and fatigue in TBI caregivers and to determine the severity of fatigue and sleep disturbance in these caregivers. Design: Cross-sectional survey data collected through an online data capture platfo...
Article
Objectives: Prophylactic levetiracetam is currently used in ~40% of patients with intracerebral hemorrhage, and the potential impact of levetircetam on health-related quality of life is unknown. We tested the hypothesis that prophylactic levetiracetam is independently associated with differences in cognitive function health-related quality of life...
Article
Background: The Functional Assessment of Cancer Therapy-Kidney Symptom Index Disease-Related Symptoms (FKSI-DRS) is important to gauge clinical benefit in metastatic renal cell carcinoma (mRCC). Objectives: To estimate important difference (ID) in FKSI-DRS scores that is considered to be meaningful when comparing treatment effect between groups,...
Article
Objectives: The goals of treating recurrent platinum-resistant ovarian cancer are palliative, aimed at reducing symptoms and improving progression free survival. A prospective trial was conducted to determine the prevalence and severity of symptoms, and associated care needs. Methods: Eligible women included those with persistent or recurrent pl...
Article
Objective: To evaluate the Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference items for use in a quality measure and to compare the resulting quality score, along with internal reliability and validity, to a similar item set in the Minimum Data Set Version 3.0 (MDS). Design: Cross-sectional, observational study....
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Background: Clinician-rated measures of functioning are often used as primary endpoints in clinical trials and other behavioral research in Huntington disease. As study costs for clinician-rated assessments are not always feasible, there is a question of whether patient self-report of commonly used clinician-rated measures may serve as acceptable...
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Purpose: Health status descriptive systems based on item response theory (IRT), such as the Patient-Reported Outcomes Measurement Information System (PROMIS®), have item banks to measure domains of health. We developed a method to present such banks for health-state valuation. Methods: We evaluated four different presentation approaches: a singl...
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Objective: To determine the extent to which the content of the Quality of Life in Neurological Disorders (Neuro-QoL) covers the ICF core sets for multiple sclerosis (MS), stroke, spinal cord injury (SCI), and traumatic brain injury (TBI) using summary linkage indicators. Design: Content analysis by linking content of the Neuro-QoL to correspondi...
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Purpose: The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. This paper describes the development of...
Article
The Testosterone Trials (TTrials) were a coordinated set of seven, placebo-controlled, double blind trials in 788 men of mean age 72 years to determine the efficacy of increasing the testosterone levels of older men with low testosterone. Testosterone treatment increased the median testosterone level from unequivocally low at baseline to midnormal...
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Purpose: While quality of life measures may be used to assess meaningful change and group differences, their scaling and validation often rely on a single occasion of measurement. Using the 13-item FACIT-Fatigue questionnaire at three timepoints, this study tests whether individual items change together in ways consistent with a general fatigue fa...
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669 Background: Traditional progression definitions based on the RECIST 1.1 criteria may lead to a premature declaration of progression due to tumor flare or pseudo-progression effects associated with I/O drugs, especially among patients with solid tumors (such as RCC). This analysis compared the Q-TWiST between nivolumab and everolimus, using both...
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TPS710 Background: The anti-PD-1 antibody nivolumab (nivo) improves overall survival (OS) in metastatic treatment refractory RCC and is generally tolerable. In 2017, there is no standard adjuvant therapy proven to increase OS over surgery alone in non-metastatic (M0) disease. Mouse solid tumor models have revealed an OS benefit with a short course...
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Purpose: Aromatase inhibitors are the most commonly prescribed adjuvant endocrine therapy for hormone-dependent early breast cancer in postmenopausal women. Among Canadian Cancer Trials Group MA.27 participants, anastrozole and exemestane had comparable 5-year event-free survival. This companion study examined differences in patient-reported treat...
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Purpose: Patient-reported outcome measures (PROMs), which are generic or condition-specific, are used for a number of reasons, including clinical care, clinical trials, and in national-level efforts to monitor the quality of health care delivery. Creating PROMs that meet different purposes without overburdening patients, healthcare systems, provid...
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Purpose of review: Diverse methodological approaches pose significant challenges to assess environmental exposure effects on child health outcomes. Although transdisciplinary research efforts offer unique opportunities for understanding the complex and multidimensional facets of lifespan health and disease trajectories, a shared measurement strate...
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400 Background: Limited information is available on the longitudinal impact of CS symptoms and QoL in CS patients (pts) who received SSAs in real-world setting. This study aimed to examine change in CS symptoms and QoL in CS pts treated with SSAs using the validated FACT-G instrument. Methods: Pts with CS symptoms in the US were recruited through a...
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BackgroundE2805 was a phase III trial to test whether adjuvant sunitinib or sorafenib could improve disease-free survival compared to placebo in patients with renal cell carcinoma. Patient-reported outcomes (PRO), focusing on fatigue, were evaluated as a secondary endpoint. Patients and methodsA total of 463 patients participated in the PRO study....
Article
Background: The EORTC QLU-C10D is a new multi-attribute utility instrument derived from the widely used cancer-specific quality-of-life (QOL) questionnaire, EORTC QLQ-C30. The QLU-C10D contains ten dimensions (Physical, Role, Social and Emotional Functioning; Pain, Fatigue, Sleep, Appetite, Nausea, Bowel Problems), each with four levels. To be used...
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Purpose: Cognitive functioning impacts health-related quality of life (HRQOL) for individuals with Huntington disease (HD). The Neuro-QoL includes two patient-reported outcome (PRO) measures of cognition-Executive Function (EF) and General Concerns (GC). These measures have not previously been validated for use in HD. The purpose of this analysis...
Article
The US Food and Drug Administration and the Critical Path Institute’s Patient-Reported Outcome (PRO) Consortium convened a cosponsored workshop on the use of PRO measures to inform the assessment of safety and tolerability in cancer clinical trials. A broad array of international stakeholders involved in oncology drug development and PRO measuremen...
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Background: The improving efficacy of cancer treatment has resulted in an increasing array of treatment-related symptoms and associated burdens imposed on individuals undergoing aggressive treatment of their disease. Often, clinical trials compare therapies that have different types, and severities, of adverse effects. Whether rated by clinicians...
Article
The aim of this study was to investigate the extent to which health-related quality of life (HRQOL) parameters have been reported in phase III trials with breast cancer patients (BCPs) who received radiation therapy (RT). We also examine the frequency and correlates of significant HRQOL gains. A systematic review was conducted. When HRQOL was a stu...
Article
Background: Our exploratory analysis examined the association between health-related quality of life (HRQoL) (baseline and change over time) and clinical outcomes (overall survival [OS]/radiographic progression-free survival [rPFS]) in metastatic castration-resistant prostate cancer (mCRPC). Methods: HRQoL, OS and rPFS were assessed in phase III...
Article
Introduction: This multicenter phase 2 study assessed the combination of estramustine and weekly paclitaxel with metastatic castration-resistant prostate cancer (CRPC). Patients and methods: We enrolled 77 patients who had received no prior chemotherapy for CRPC between 1998 and 2000; a total of 74 subjects were eligible for the study. Each 8-we...
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Background: Huntington's disease (HD), is a neurodegenerative disorder that is associated with cognitive, behavioral, and motor impairments that diminish health related quality of life (HRQOL). The HD-PRO-TRIADTM is a quality of life measure that assesses health concerns specific to individuals with HD. Preliminary psychometric characterization wa...
Article
Patient-reported outcomes (PROs) are playing an increasing role in multiple sclerosis (MS) research and practice, and are essential for understanding the effects that MS and MS treatments have on patients' lives. PROs are captured directly from patients and include symptoms, function, health status, and health-related quality of life. In this artic...
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Background: Measuring patient-reported outcomes (PROs) is becoming an integral component of quality improvement initiatives, clinical care, and research studies in cancer, including comparative effectiveness research. However, the number of PROs limits comparability across studies. Herein, the authors attempted to link the Functional Assessment of...
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Purpose: We sought to select a parsimonious subset of domains from the patient-reported outcomes measurement information system (PROMIS(®)) that could be used for preference-based valuation. Domain selection criteria included face validity, comprehensiveness, and structural independence. Methods: First, 9 health outcomes measurement experts sele...
Article
Context: Monitoring of health-related quality of life (HRQOL) and symptoms of patients with brain tumors is needed yet not always feasible. This is partially due to lack of brief-yet-precise assessments with minimal administration burden that are easily incorporated into clinics. Dynamic computerized adaptive testing (CAT) or static fixed-length s...