Elizabeth D Bacci

Evidera · Outcomes Research

Introduction The Leicester Cough Questionnaire (LCQ), a cough-specific quality-of-life measure, evaluates the impact of cough across physical, psychological, and social domains in patients with chronic cough (CC). This study assessed the psychometric properties of the LCQ. Methods Data from a phase IIb, randomized controlled trial of the P2X3-rece...

Background The prevalence of nocturnal polyuria (NP), which is passing large volumes of urine during the main sleep period, has been investigated primarily in middle-aged to older men. There is thus a gap in the NP evidence base for women and for younger individuals. Objective To estimate the prevalence of nocturia due to NP in the USA. Design, s...

Introduction: Patients with chronic cough experience considerable burden. The cough severity visual analog scale (VAS) records patients' assessment of cough severity on a 100-mm linear scale ranging from "no cough" (0 mm) to "worst cough" (100 mm). Although cough severity scales are widely used in clinical practice and research, their use in patie...

IntroductionThe incidence and prevalence of type 2 diabetes mellitus (T2D) are increasing in Japan, and glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are commonly used to treat the disease. The objective of this study was to use a discrete choice experiment (DCE) to characterize patient preferences for clinical treatment features of two GLP...

Background: COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE™) uses five questions and peak expiratory flow (PEF) thresholds (males ≤350 L/min; females ≤250 L/min) to identify patients with a forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) <0.70 and FEV1 <60% predict...

Background The inFLUenza Patient Reported Outcome (FLU-PRO) measure is a daily diary assessing signs/symptoms of influenza across six body systems: Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal, Body/Systemic, developed and tested in adults with influenza.Objectives This study tested the reliability, validity, and responsiveness of FLU-PR...

Online supplement: Table A. Patient Demographic and Clinical Characteristics by Hospitalization Status (N = 220) Table B. FLU-PRO Domain and Total Score Descriptive Statistics in Non-Hospitalized Patients—Day 1 Table C. FLU-PRO Domain and Total Score Descriptive Statistics in Hospitalized Patients—Day 1 Table D. Two-day Reliability of FLU-PRO—Days...

Background To assess the reliability, validity, and responsiveness to treatment change of the single-item measure, Severity of Worst Tiredness, in patients with rheumatoid arthritis (RA). Methods Data from two Phase 3, randomized, placebo-controlled (RA-BUILD; and active-controlled [RA-BEAM]), clinical studies of the efficacy of baricitinib in adu...

Background To assess the measurement properties of two single-item patient-reported outcome (PRO) measures that assessed the length of time (in minutes) and severity of morning joint stiffness (MJS) experienced each day. Methods Data from two Phase 3, randomized placebo-controlled (and active-controlled [RA-BEAM]), clinical studies assessing the s...

Background There are no validated patient diaries for evaluating respiratory symptoms in idiopathic pulmonary fibrosis (IPF). Purpose To evaluate the performance properties of the chronic obstructive pulmonary disease (COPD) Evaluating Respiratory Symptoms™ (E-RS™: COPD) measure in patients with IPF. Methods Concept elicitation and cognitive inte...

Objectives To assess the reliability, validity, and responsiveness of InFLUenza Patient-Reported Outcome (FLU-PRO©) scores for quantifying the presence and severity of influenza symptoms. Methods An observational prospective cohort study of adults (≥18 years) with influenza-like illness in the United States, the United Kingdom, Mexico, and South A...

Objective: Develop a method for identifying undiagnosed COPD requiring treatment with currently available therapies (FEV1 <60% predicted and/or exacerbation risk). Methods: Multi-site, cross-sectional, case-control study in U.S. pulmonary and primary care clinics that recruited subjects from primary care settings. Cases: COPD and ≥ 1 exacerbat...

Background Investigations using classical test theory support the psychometric properties of the original version of the Multiple Sclerosis Impact Scale (MSIS-29v1), a disease-specific measure of multiple sclerosis (MS) impact (physical and psychological subscales). Later, assessments of the MSIS-29v1 in an MS community-based sample using Rasch ana...

Content validity of the 18-item Investigator-Rated Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale IV (I-ADHD RS-IV) with adult prompts was investigated using qualitative interviews of US clinicians who had prior experience rating adults with phenylketonuria (PKU) using the I-ADHD RS-IV. Fourteen qualitative interviews were conducted t...

Adults with phenylketonuria (PKU) experience disturbances in mood. This study used qualitative and quantitative techniques to adapt the 65-item Profile of Mood States (POMS) for the assessment of key mood domains in adults with PKU. First, cognitive interviews on 58 POMS items (excluding 7 Friendliness domain items) among 15 adults and adolescents...

Objective: The objective of this study was to use a discrete choice experiment (DCE) to estimate patients' preferences for the treatment features, safety, and efficacy of two specific glucagon-like peptide-1 receptor agonists, dulaglutide and liraglutide, among patients with type 2 diabetes mellitus (T2DM) in Japan. Methods: In Japan, patients w...

Background Depressive symptoms associated with bipolar disorder negatively impact health-related quality of life (HRQoL). The efficacy of lurasidone in reducing depressive symptoms has been previously demonstrated. The objective of this study was to examine the direct and indirect effect (mediated through improvement in depression symptoms) of lura...

Clinical trial participants often require additional instruction to prevent idiosyncratic interpretations regarding completion of patient-reported outcomes (PROs). The Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership developed a training system with speci...

Background: Bipolar depression is characterized by depressive symptoms and impairment in many areas of functioning, including work, family, and social life. The objective of this study was to assess the independent, direct effect of lurasidone treatment on functioning improvement, and examine the indirect effect of lurasidone treatment on function...

Background To develop content validity of a comprehensive patient-reported outcome (PRO) measure following current best scientific methodology to standardize assessment of influenza (flu) symptoms in clinical research. Methods Stage I (Concept Elicitation): 1:1 telephone interviews with influenza-positive adults (≥18 years) in the US and Mexico wi...

Estimate the proportion of lurasidone-treated patients with bipolar depression who achieved a clinically meaningful improvement in health-related quality of life (HRQoL) as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q SF). A post-hoc analysis of data from two 6-week, randomized, placebo-controlled cli...

Our objective was to examine dimensionality and item-level performance of the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) across time using classical and modern test theory approaches. Confirmatory factor analysis (CFA) and Item Response Theory (IRT) analyses were conducted using data from patients with amyotrophic late...

Background: COPD is underdiagnosed, often uncovered during exacerbations or after significant loss of lung function. We are developing a new method (simple questionnaire + peak expiratory flow [PEF]) for identifying patients needing spirometric evaluation for clinically significant COPD (FEV1 <60% pred) or at risk of acute exacerbation (AECOPD) in...

This study was designed to gain insight into the apparent contradiction between the perspectives of researchers and policy makers, who have questioned the efficacy and safety of chronic opioid therapy for non-cancer pain patients, and the patients themselves, who often indicate that the therapy has value. A convenience sample of 54 patients on chro...

Many cases of chronic obstructive pulmonary disease (COPD) are diagnosed only after significant loss of lung function or during exacerbations. This study is part of a multi-method approach to develop a new screening instrument for identifying undiagnosed, clinically significant COPD in primary care. Subjects with varied histories of COPD diagnosis,...

Rationale: This study is part of a larger, multi-method project to develop a questionnaire for identifying undiagnosed cases of chronic obstructive pulmonary disease (COPD) in primary care settings, with specific interest in the detection of patients with moderate to severe airway obstruction or risk of exacerbation. Objectives: To examine 3 exi...

Background Symptomatic relief is an important treatment goal for patients with COPD. To date, no diary for evaluating respiratory symptoms in clinical trials has been developed and scientifically-validated according to FDA and EMA guidelines. The EXACT ¿ Respiratory Symptoms (E-RS) scale is a patient-reported outcome (PRO) measure designed to addre...

Cultural factors are associated with health behaviors among American Indians. Accordingly, the objective of our study was to investigate whether cultural identity, defined as the primary language spoken at home, is associated with: 1) higher total physical activity levels, and 2) levels of leisure-time physical activity recommended for health benef...

Chronic widespread pain (CWP) is a common and potentially debilitating disorder. Patterns of physical activity (PA) in adults with CWP have primarily been investigated using subjective, self-report measures. The current study sought to characterize PA among community-dwelling individuals with CWP, chronic regional pain (CRP), or no chronic pain (NC...

Tamper-resistant opioid formulations (TRFs) have recently been the target of active development in an effort to deter opioid misuse and abuse. To understand factors that are predictive of physicians' likelihoods of prescribing TRFs to patients with chronic noncancer pain (CNCP). A cross-sectional survey was conducted, utilizing a questionnaire of c...

Objective: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality, yet research suggests this disease is greatly underdiagnosed. This literature review sought to summarize the most common and significant variables associated with case-finding or missed cases of COPD to inform more effective and efficient detection...

This study sought to determine the prevalence and impact of pain in a nationally representative sample of older adults in the United States. Data from the 2011 National Health and Aging Trends Study were analyzed. In-person interviews were conducted in 7601 adults ages ⩾65years. The response rate was 71.0% and all analyses were weighted to account...

Informal caregiving can be deleterious to mental health, but research results are inconsistent and may reflect an interaction between caregiving and vulnerability to stress. We examined psychological distress among 1,228 female caregiving and non-caregiving twins. By examining monozygotic and dizygotic twin pairs discordant for caregiving, we asses...

SUMMARY Chronic pain affects a wide range of outcomes that are typically assessed using self-reported methodologies, which are susceptible to recall biases, current mood and pain intensity. Physical activity (PA) is an important component of the pain experience that can be objectively assessed with accelerometers, which are small, lightweight devic...

There is a dearth of knowledge about the link between cortisol and pain sensitivity. We examined the association of salivary cortisol with indices of cold pain sensitivity in 198 female twins and explored the role of familial confounding. Three-day saliva samples were collected for cortisol levels and a cold pressor test was used to collect pain ra...

Chronic pain is a public health concern affecting 20-30% of the population of Western countries. Although there have been many scientific advances in the understanding of the neurophysiology of pain, precisely assessing and diagnosing a patient's chronic pain problem is not straightforward or well-defined. How chronic pain is conceptualized influen...

Background: Previous studies suggest that acculturation may influence the experience of pain. Study design: We conducted a cross-sectional study to estimate the association between acculturation and the prevalence, intensity, and functional limitations of pain in older Hispanic adults in the United States. Methods subjects: Participants were E...

Objective: This study examined if associations between body mass index (BMI) and mental and physical health were independent of genetic and familial factors. Method: Data from 2831 twins (66% female) were used in an epidemiological co-twin control design with measures of BMI and mental and physical health outcomes. Generalized estimating equatio...

Unlabelled: Beliefs surrounding the use of opioids for chronic noncancer pain have vacillated over time. Concerns regarding long-term efficacy and adverse effects of opioids, along with increases in opioid prescribing, have contributed to many political, regulatory, and clinical responses. The present study was designed to (1) develop a reliable a...

Background: The etiology of chronic fatigue syndrome (CFS) remains unknown. Personality traits influence well-being and may play a role in CFS and unexplained chronic fatigue. Purpose: This study aimed to examine the association of emotional instability and extraversion with chronic fatigue and CFS in a genetically informative sample. Methods:...

Introduction: Chronic pain is a public health concern, and in the last decade, there has been a dramatic increase in the use and abuse of prescription opioids for chronic non-cancer pain. Methods: We present an overview of a five-component model of pain management implemented at the University of Washington Division of Pain Medicine designed to...

Fear and avoidance of activity may play a role in fostering disability in whiplash-associated disorders (WAD). This study examined the role of fear after WAD and assessed the effectiveness of 3 treatments targeting fear. People still symptomatic from WAD grade I-II injuries approximately 3months previously (n=191) completed questionnaires (eg, Neck...

Chronic fatigue syndrome (CFS) has been found to be comorbid with various medical conditions in clinical samples, but little research has investigated CFS comorbidity in population-based samples. This study investigated conditions concurrent with a CFS-like illness among twins in the population-based Mid-Atlantic Twin Registry (MATR), including chr...

Data from primary care and community samples suggest higher rates of post-traumatic stress disorder (PTSD) among individuals with chronic fatigue syndrome (CFS). This study investigated the co-occurrence of CFS, PTSD, and trauma symptoms and assessed the contribution of familial factors to the association of CFS with lifetime PTSD and current traum...

The present study investigated the validity of the construct of fear of criminal victimization, and identified factors associated with fear and crime prevention behaviors using a nationally representative sample from 12 US cities. Confirmatory factor analysis and structural equation modeling analyses indicated that along with individual-level chara...

Throughout the empirical psychological literature on emotion, the general consensus is that shame is maladaptive, while guilt is the adaptive moral emotion. Conversely, evolutionary psychology concludes that all emotions serve adaptive functions. Specifically, shame serves an appeasement function in social relationships. In order to investigate the...