Publications by authors named "Cristian Gugiu"

Objective: Nasal Polyp Score (NPS) and Nasal Congestion Score (NCS) are commonly used clinical trial endpoints to determine improvements in response to treatment in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). However, limited information is available on within-patient meaningful change thresholds (MCTs) and between-group minimal important differences (MIDs) for NPS and NCS, which would aid interpretation of results.

Methods: Data from phase 3 placebo-controlled trials of omalizumab in patients with CRSwNP (POLYP 1 and POLYP 2) were used to estimate MCTs and MIDs for both NPS and NCS using anchor-based methods.

View Article and Find Full Text PDF

Objectives: This study aimed to assess the content validity and reliability of the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) by rheumatologists treating patients with psoriatic arthritis.

Methods: There were 3 stages of analyses with 3 clinician cohort groups. Stage 1 (concept confirmation) included rheumatologist qualitative data (cohort 1) to establish content validity, acceptability, utility, and feasibility of the PGA-F in assessing nail severity.

View Article and Find Full Text PDF

This paper evaluated the evidence supporting the factor structure of extant coping instruments based on modern psychometric standards. Our literature search identified nine coping instruments that are routinely used to measure coping strategies in adult populations. While nearly 10 thousand papers have been published using these instruments, only 39 studies have investigated their psychometric validity.

View Article and Find Full Text PDF

To understand factors that may influence father involvement, researchers have increasingly considered maternal gatekeeping, or the extent to which mothers might attempt to regulate (i.e., encourage, discourage) fathers' involvement in childrearing.

View Article and Find Full Text PDF

Background: The Itch Numeric Rating Scale (NRS), Skin Pain NRS, and Atopic Dermatitis Sleep Scale (ADSS) are self-administered patient-reported outcome (PRO) instruments developed to assess symptoms in patients with atopic dermatitis (AD). The objective of this study was to evaluate the psychometric properties (reliability, validity, and responsiveness) and interpretability thresholds of these PROs using data from three pivotal Phase 3 studies in adults.

Methods: BREEZE-AD1, BREEZE-AD2, and BREEZE-AD5 evaluated the safety and efficacy of baricitinib in adults with moderate-to-severe AD.

View Article and Find Full Text PDF

Increased interest in disseminating and implementing psychological treatments has focused on the need for evidence-based training programs for providers, especially those without specialized training. To evaluate provider-training programs, validated outcome measures are necessary; however, the scalable measurement of training outcomes has been largely overlooked. Current methods of assessing providers' ability to deliver psychological treatments are generally time-consuming and costly, representing a major bottleneck in scaling up mental health care for commonly occurring disorders such as depression.

View Article and Find Full Text PDF

Background: Despite strong prevention efforts and advances in neonatal care in recent decades, low birth weight remains a serious public health problem in the United States, and survivors remain at increased risk for lifelong problems including cognitive deficits. Current regional and local strategies for referral often rely on variable thresholds for birth weight and gestational age that may be poor analogues to cognitive risk. Improving early referral criteria offers many benefits, including improved cognitive outcomes for children and improved cost-effectiveness and resource utilization in resource-limited communities.

View Article and Find Full Text PDF

Low birth weight is an ongoing public health problem with severe consequences for those affected, including early morbidity and mortality and elevated risk for lifelong deficits in cognitive function. These deficits can be ameliorated by early intervention in many cases. To contribute to criteria for earlier identification of at-risk children prior to the onset of delays or deficits, we examined relationships between three gene candidates-, , and cognitive outcomes at school age in a secondary analysis of existing data from a nationally representative cohort.

View Article and Find Full Text PDF

Unlabelled: Construct: Burnout is a psychological construct characterized by emotional exhaustion that arises from an excess of physical, emotional, and social demands over an extended period. Symptoms of burnout include withdrawal or disengagement from work. Burnout has become an important public health concern due to its association with severe negative consequences across numerous professions.

View Article and Find Full Text PDF

This secondary analysis quantified the psychometric properties of the Ohio Modified Arm-Motor Ability Test (OMAAT) in a sample of neurologically stable chronic stroke survivors (n = 67, 40 men; mean age 59.8 yr, standard deviation = 12.8; 42 White, 23 Black, 2 other; 92.

View Article and Find Full Text PDF

Objective: The objective of this study was to determine the psychometric properties of the Vocational Fit Assessment (VFA) by examining its factor structure and subscale reliability.

Method: This prospective cross-sectional study used two surveys (one for worker abilities and one for job demands) to collect the data needed for the psychometric evaluation of the VFA. Latent parallel analysis and ordinal exploratory factor analysis were used to iteratively refine VFA subscales.

View Article and Find Full Text PDF

Background And Purpose: Clinical administration of the wrist stability, wrist mobility, and hand items of the upper-extremity Fugl-Meyer (W/H UE FM) may provide a rigorous, easily administered, bedside measure of motor impairment in mildly impaired stroke survivors. The purpose of this study was to evaluate the item structure of the W/H UE FM to better understand its measurement properties using Rasch analysis.

Methods: This was a secondary analysis of W/H UE FM data arising from clinical trials of mildly impaired stroke survivors using latent parallel analysis, ordinal factor analysis, and partial credit model Rasch analyses.

View Article and Find Full Text PDF

Despite more than 30 years of effort that has been dedicated to the improvement of grading systems for evaluating the quality of research study designs considerable shortcomings continue. These shortcomings include the failure to define key terms, provide a comprehensive list of design flaws, demonstrate the reliability of such grading systems, properly value non-randomized controlled trials, and develop theoretically-derived systems for penalizing and promoting the evidence generated by a study. Consequently, in light of the importance of grading guidelines in evidence-based medicine, steps must be taken to remedy these deficiencies.

View Article and Find Full Text PDF

Increasing emphasis is being placed on measuring return on research investment and determining the true impacts of biomedical research for medical practice and population health. This article describes initial progress on development of a new standardized tool for identifying and measuring impacts across research sites. The Translational Research Impact Scale (TRIS) is intended to provide a systematic approach to assessing impact levels using a set of 72 impact indicators organized into three broad research impact domains and nine subdomains.

View Article and Find Full Text PDF

Methodological quality undergirds all evidence-based medicine because without strong evidence supporting or refuting the efficacy of an intervention, the movement toward basing medical decisions and practice on scientific evidence is not sustainable. Recently, the consensus that had existed regarding the hierarchy of evidence produced by a study design was challenged on the basis that existing guidelines failed to properly define key terms, weight the merits of certain non-randomized controlled trials, and employ a comprehensive list of study design limitations to render evaluative conclusions, to name a few of the challenges. The present study introduces a new grading system that overcomes, or at the very least greatly diminishes, these challenges.

View Article and Find Full Text PDF

Over the past 30 years, a general consensus has emerged within the medical community regarding the essential role served by grading guidelines in evaluating the quality of evidence produced by a medical research study. Specifically, consensus exists regarding the hierarchy of evidence, where randomized controlled trials (RCTs) are considered the ''gold standard'' followed by nonrandomized controlled trials (non-RCTs) and uncontrolled trials. As guidelines have become more sophisticated, processes have been developed for downgrading poorly conducted studies and upgrading strong studies.

View Article and Find Full Text PDF

Objective: In this study, the authors investigated the psychometric properties of a modified version of the Patient Assessment of Chronic Illness Care (PACIC) - a self-report instrument designed to measure the extent to which patients with chronic illness receive care congruent with the chronic care model.

Research Design And Method: Five hundred and twenty-nine (529) type 2 diabetics were surveyed with a modified-PACIC.

Results: An exploratory and confirmatory factor analysis was conducted that accounted for the ordinal nature of the PACIC items.

View Article and Find Full Text PDF

Objectives: The Patient Assessment of Chronic Illness Care (PACIC) was developed for measuring the extent to which patients receive care congruent with the chronic care model (CCM). The purpose of this study was to develop a short version of the PACIC with better psychometric properties than the original instrument.

Methods: Two samples of 529 and 361 type 2 diabetic patients completed a modified PACIC.

View Article and Find Full Text PDF

This paper details a semi-structured interview protocol that evaluators can use to develop a logic model of a program's services and outcomes. The protocol presents a series of questions, which evaluators can ask of specific program informants, that are designed to: (1) identify key informants basic background and contextual information, (2) generate logic model elements, (3) model program inputs, activities, outputs, and outcomes, (4) build a rational theory, (5) develop a program theory, (6) prioritize logic model elements, and (7) build a graphical or tabular logic model. The paper will also provide an example of how this approach was used to develop a logic model for a youth mentoring program.

View Article and Find Full Text PDF