Abstract Background Bowel urgency, the sudden or immediate need to have a bowel movement, is common, bothersome and disruptive symptom of ulcerative colitis (UC). UC treatment goals include control urgency; however, it not consistently assessed in clinical trials. The Urgency Numeric Rating Scale (NRS) new patient-reported measure assess severity urgency adults with developed accordance Food Drug Administration guidelines. Methods Qualitative interviews were used develop NRS. scale asks...

Abstract Background Bowel urgency is commonly experienced by patients with ulcerative colitis (UC) and associated reduced health-related quality of life (QoL). Mirikizumab, a humanized monoclonal antibody directed against the p19 subunit IL-23, significantly bowel in double-blind, randomized, placebo-controlled Phase 2 clinical trial moderate-to-severe UC (NCT02589665). Methods All (N = 249) reported symptoms including absence or presence urgency. Absence was defined as no for 3 consecutive...

In patients with ulcerative colitis (UC) and Crohn's disease (CD), this research examined the following: prevalence of fecal urgency (hereafter urgency), association inflammatory bowel (IBD) symptoms calprotectin, between well-being urgency.In cross-sectional study from Study a Prospective Adult Research Cohort IBD, was categorized as none, mild, moderate-severe. We urgency, IBD calprotectin (in subset) using multinomial logistic regression, (not feeling well vs generally well)...

To assess the prevalence of fatigue and its association with disease activity patient-reported outcomes among patients ulcerative colitis (UC) or Crohn's (CD). Data from a cross-sectional survey conducted gastroenterologists their consulting adult UC CD were analyzed. collected via gastroenterologist-completed patient record forms patient-self completion forms. Patient demographics, clinical characteristics, medication use reported by gastroenterologist, while current symptoms (fatigue,...

The ICH E9(R1) addendum (2019) proposed principal stratification (PS) as one of five strategies for dealing with intercurrent events. Therefore, understanding the strengths, limitations, and assumptions PS is important broad community clinical trialists. Many approaches have been developed under general framework in different areas research, including experimental observational studies. These diverse applications utilized a set tools assumptions. Thus, need exists to present these unifying...

Abstract Background The Urgency Numeric Rating Scale (NRS) was developed as a content-valid single-item patient-reported outcome measure to assess severity of bowel urgency. Here, we evaluated the psychometric properties NRS. Methods Data were from multicenter, randomized, placebo-controlled phase 3 trial in adults with moderately severely active ulcerative colitis (NCT03518086). Patients completed NRS using daily electronic diary, which weekly average scores calculated. Test–retest...

Objective Mirikizumab, a monoclonal antibody targeting the interleukin-23 p19 subunit, was effective in Phase 2 study ( NCT02589665 ) of moderately-to-severely active ulcerative colitis (UC). We studied mirikizumab’s impact on health-related quality life (HRQoL). Design HRQoL evaluated using Inflammatory Bowel Disease Questionnaire (IBDQ) and 36-Item Short Form Health Survey (SF-36) Physical Component Score (PCS) Mental (MCS). Mixed effects models for repeated measures compared score changes...

Background: Access to social services (eg, nutrition) can impact older adults’ health care utilization and outcomes. However, data documenting the relationship between receiving objective measures of remain limited. Objectives: To link Meals on Wheels (MOW) program Medicare claims enable examination clients’ highlight utility this linked dataset. Research Design: Using probabilistic linking techniques, we matched MOW client enrollment data. Descriptive information is presented before after...

We compared pain medication use in patients with ankylosing spondylitis (AS), psoriatic arthritis (PsA), and rheumatoid (RA) versus matched control over 2 years; a subgroup analysis assessed changes who initiated biologic during 12 months before after. This was retrospective observational cohort study using an administrative claims database. Newly diagnosed adult AS, PsA, or RA identified between 1/1/2014 7/31/2017 were included. Demographics, baseline characteristics, described descriptive...

Objective Few studies have examined the association between inflammatory bowel disease (IBD) severity, and humanistic, economic burden. We addressed this gap using a unique real-world data source that links self-reported patient from US National Health Wellness Survey (NHWS) to claims data.Methods This cross-sectional study linked 2015–2018 NHWS with medical, pharmacy claims. Patients (≥18 years) who physician diagnosis of IBD (ulcerative colitis [UC], or Crohn's [CD]) in NHWS, had medical...

The purpose of this analysis was to assess the frequency inadequate response over 1 year from advanced therapy initiation among patients with Crohn's disease (CD) or ulcerative colitis (UC) in United States using a claims-based algorithm. Factors associated were also analyzed.This study utilized claims data adult HealthCore Integrated Research Database (HIRD®) January 01, 2016 August 31, 2019. Advanced therapies used tumor necrosis factor inhibitors (TNFi) and non-TNFi biologics. Inadequate...

Ixekizumab, an interleukin-17A antibody, has shown efficacy in non-radiographic axial spondyloarthritis (nr-axSpA). The objectives of this analysis were (a) to measure improvement ixekizumab-treated patients Assessment Spondyloarthritis International Society (ASAS) response domains and other patient-reported outcomes (PROs) (b) determine how ASAS responses associated with changes patient global disease activity (PtGA), spinal pain, function, stiffness, fatigue, pain at night. COAST-X was a...

Rectal urgency is a common but under-reported inflammatory bowel disease (IBD) symptom. The present study assessed the prevalence of rectal and its association with activity patient-reported outcomes (PROs) among patients ulcerative colitis (UC) or Crohn's (CD) in real-world setting.Data were drawn from 2017-2018 Adelphi IBD Disease Specific Programme™, multi-center, point-in-time survey gastroenterologists consulting adult UC CD France, Germany, Italy, Spain, United Kingdom, States....

The assumption of ‘no unmeasured confounders’ is a critical but unverifiable required for causal inference yet quantitative sensitivity analyses to assess robustness real-world evidence remains underutilized. lack use likely in part due complexity implementation and often specific restrictive data requirements application each method. With the advent methods that are broadly applicable they do not require identification confounder – along with publicly available code roadblocks toward...

Summary Understanding associations between injury severity and postacute care recovery for patients with traumatic brain (TBI) is crucial to improving care. Estimating these requires information on patients’ injury, demographics, healthcare utilization, which are dispersed across multiple data sets. Because of privacy regulations, unique identifiers not available link records Record linkage methods identify that represent the same patient sets in absence identifiers. With a large number...

Abstract Background Although various treatments help reduce abdominal pain, real-world pain medication utilization among patients with Crohn’s disease (CD) or ulcerative colitis (UC) receiving advanced therapies is poorly understood. The aim to understand the of 12 months before and after initiation newly diagnosed CD UC. Methods This retrospective, observational cohort study used administrative medical pharmacy claims data UC from HealthCore Integrated Research Database (HIRD ® ). use over...

Fatigue imposes a socioeconomic burden on patients with Crohn's disease (CD) and ulcerative colitis (UC). We assessed the prevalence of fatigue among CD or UC identified activity measures associated fatigue.

To assess the impact of home-delivered meals programs offered by Meals on Wheels (MOW) a dataset that includes enrollment into MOW and healthcare utilization is required. Because confidentiality restrictions this data dispersed over internal systems Medicare claims. In absence unique identifying identifiers, beneficiaries are linked to using probabilistic linking algorithm. However, procedure may erroneously link individuals across two datasets, which result in biased treatment effect...

In many healthcare and social science applications, information about units is dispersed across multiple data files. Linking records files necessary to estimate associations between variables exclusive each of the Common record linkage algorithms only rely on similarities linking common all Moreover, analysis linked often ignores errors that may arise from incorrect or missed links. Bayesian methods allow for natural propagation errors, by jointly sampling structure model parameters. We...

Abstract Aiming at the problems of spectrum leakage, difficulty in guaranteeing demodulation accuracy, and endangering driving safety signal detection algorithm based on periodogram with limited sampling duration, this paper proposes for first time a kind ZPW-20000 frequency-shift nonlinear least squares, so as to improve performance ZPW-2000 signal, ensure safe operation trains, operational efficiency. The mathematical model is established, Cramér-Rao bound (CRB) carrier-frequency...