Search

IntroductionAs new topical and systemic treatments become available for atopic dermatitis (AD), there is a need to understand how treatments are being used in routine clinical practice, their comparative effectiveness and their long-term safety in diverse clinical settings.Methods and analysisThe TARGET-DERM AD cohort is a longitudinal, observational study of patients with AD of all ages, designed to provide practical information on long-term effectiveness and safety unobtainable in traditional registration trials. Patients with physician-diagnosed AD receiving prescription treatment (topical or systemic) will be enrolled at academic and community clinical centres. Up to 3 years of retrospective medical records, 5 years of prospective medical records, and optional biological samples and patient-reported outcomes will be collected. The primary aims include characterisation of AD treatment regimens, evaluation of response to therapy, and description of adverse events.Ethics and disseminationTARGET-DERM has been approved by a central IRB (Copernicus Group IRB, 5000 Centregreen Way Suite 200, Cary, North Carolina 27513) as well as local and institutional IRBs. No additional Ethics Committee reviews. Results will be reviewed by a publications committee and submitted to peer-reviewed journals.Trial registration numberNCT03661866, pre-results.

Primary biliary cholangitis (PBC) is a rare chronic cholestatic liver disease that may progress to biliary cirrhosis if left untreated. The first-line therapy for PBC is ursodeoxycholic acid (UDCA). Unfortunately, 1 of 3 patients does not respond to UDCA. These patients are at risk for developing clinical events, including cirrhosis, complications of portal hypertension, hepatocellular carcinoma, liver transplant, or death. Recently, the U.S. Food and Drug Administration approved obeticholic acid to be used in certain patients with PBC. Off-label therapies are also used, and several other therapies are currently under evaluation. Real-world effectiveness of newly approved and off-label therapies remains unknown. TARGET-PBC is a 5-year, longitudinal, observational study of patients with PBC that will evaluate the effectiveness of clinical practice interventions and provide practical information unobtainable in registration trials. Enrollment will take place at both academic and community sites. In addition to consenting to medical records review, participants will be asked to provide an annual blood sample and complete patient reported outcome surveys at predetermined intervals. Any available liver biopsies will be digitally preserved. Conclusion: Key study outcomes will be the evaluation of the safety and effectiveness of PBC interventions and the assessment of disease progression under real-world conditions. (Hepatology Communications 2018;2:484-491).

Introduction/Background Atopic dermatitis (AD) patients undergoing treatment may only experience partial improvements in their itch and skin lesions. However, partial improvement may not translate into optimal patient outcomes. There is limited evidence describing the impact of achieving higher efficacy measures in AD. Objectives To assess the independent and combined effects of itch and skin of improvement on patient-reported symptoms and quality-of-life outcomes. Methods The study included adult participants (age ≥18 years) with AD enrolled in TARGET-DERM AD, an observational, longitudinal study of >4,000 participants across 52 academic/community centers in the United States and Canada. Itch severity was assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Itch-Severity[3] item evaluating "itch at its worst" on a 0–10 numeric rating scale (NRS). A score of 0 or 1 indicated no/minimal itch (NRS-Itch 0/1). Skin severity was assessed by the validated Investigator Global Assessment of AD (vIGA-AD), with 0 or 1 representing clear/almost clear skin (vIGA-AD 0/1). The association of itch and skin severity with scores representing an ideal state in AD symptoms and quality of life outcomes were assessed as follows: patient-reported clear/almost clear disease (Patient-Oriented Eczema Measure [POEM] 0–2), little or no impact of AD on quality of life (Dermatology Life Quality Index [DLQI] 0/1), little or no sleep impact (NRS-Sleep 0/1), and little or no pain (NRS-Pain 0/1). Associations were assessed using descriptive statistics and logistic regression models including main and interaction effects for itch and skin severity. Results Among adult participants (n=1920; mean age 45 years, 59% female; 55% Non-Hispanic White), data was available from participants at enrollment for the outcomes as follows: vIGA-AD (99%, 1,913), NRS-Itch (54%, 1,042), DLQI (50%, 967), POEM (51%, 974), NRS-Sleep (50%, 958), and NRS-Pain (50%, 965). The proportion reporting ideal state scores was highest among those with NRS-Itch 0/1 (52% DLQI 0/1; 54% POEM 0–2; 57% NRS-Sleep 0/1; 83% NRS-Pain 0/1) and clear/almost clear skin (45% DLQI 0/1; 44% POEM 0–2; 45% NRS-Sleep 0/1; 74% NRS-Pain 0/1), with decreasing proportions generally observed at greater itch and skin severity levels. Among patients who had vIGA-AD 0/1, the proportion of participants with an ideal state score for all PROs increases substantially when patients also attain NRS itch 0/1: 69% DLQI 0/1, 78% POEM 0–2, 68% NRS-Sleep 0/1, and 92% NRS-Pain 0/1. The adjusted odds ratio of reporting DLQI 0/1, POEM 0–2, NRS-Sleep 0/1, and NRS-Pain 0/1 was highest among those with both no/minimal itch and clear/almost clear skin (20.0, 41.6, 6.0, and 16.1, respectively), followed by no/minimal itch only (6.1, 6.7, 3.1, and 4.3, respectively), and clear/almost clear skin only (4.4, 5.0, 1.6, and 3.0, respectively). Conclusions Achieving complete or almost complete resolution of itch and skin lesions is associated with greater odds of achieving an ideal state in terms of patient reported symptoms and quality of life (DLQI, POEM, NRS-Sleep, and NRS-Pain) with itch relief exhibiting a slightly higher impact than skin clearance. These results underscore the importance of assessing and documenting both itch severity and skin clearance to support shared decision-making. Moreover, simultaneous resolution of both itch and skin lesions should be considered when setting treatment goals in AD patients. [ABSTRACT FROM AUTHOR]

Background Therapeutic inertia, defined as the delay or reluctance in modifying treatment when goals are unmet, is a significant challenge in managing chronic diseases, including atopic dermatitis (AD). This inertia can lead to suboptimal control of the disease, affecting patient outcomes. Objectives: This study aims to evaluate the effect of therapeutic inertia on patient-reported outcomes (PROs) in individuals with moderate-to-severe AD undergoing systemic treatment over 3 to 12 months. Methods: We analyzed longitudinal data from the TARGET-DERM AD registry, which includes 3,457 patients with moderate-to-severe AD from 39 centers across the U.S. and Canada. Eligible patients had documented outcomes at the initiation of systemic therapy and at subsequent 3-month intervals up to 12 months of follow-up. We assessed patient-reported outcomes (PROs) to determine the proportion of patients not meeting predefined treatment targets for PROs based on expert consensus. Patients had a validated Investigator Global Assessment (vIGA-AD) score of 3 or more at initiation of either an advanced systemic therapy (AST) such as biologics or JAK inhibitors or a conventional systemic therapy (CST) such as cyclosporine, methotrexate, or prednisone. PROs were evaluated at 3-month intervals up to 12 months, assessing achievement against predefined treatment targets based on expert consensus. PRO measures included Worst-Itch (PROMIS Itch-Severity), POEM, PO-SCORAD, NRS-sleep, and NRS-pain with specific moderate and optimal target levels established for each. Itch-Severity (range: 0-10; moderate target: ≥4-point reduction, optimal target: score ≤1), POEM (range: 0-28; moderate target: ≥4-point reduction, optimal target: score ≤2), PO-SCORAD (range: 0-103; moderate target: score ≤24; optimal target: score ≤10), NRS-sleep and NRS-pain (range: 0-10; moderate target: reduction ≥3-points; optimal target: score ≤1). Results: Out of 2107 patients with moderate-to-severe AD, 445 qualifying participants were included (63.8% adult, 62.0% female, 45.4% Non-Hispanic White, mean age of 31 years). Most patients (88.8%) initiated AST, with dupilumab being the most common (86.5%). At 6 months, significant proportions of AST-treated patients failed to reach moderate and optimal targets for itch (67% and 79%, respectively), POEM (46% and 69%), and NRS-sleep (59% and 47%). By 12 months, these figures were similar, with 66% and 88% failing to meet itch targets, 53% and 73% failing to meet POEM targets, and 62% and 45% failing to meet NRS-sleep targets, respectively. A similar pattern was observed for other PROs. CST-treated patients exhibited similar trends. Conclusions: The study highlights the profound impact of therapeutic inertia on the quality of life of patients with moderate-to-severe AD. Despite systemic therapy, a considerable proportion failed to meet treatment targets over a 12-month period, underscoring the need for more proactive and responsive treatment strategies in AD management. [ABSTRACT FROM AUTHOR]

Background Therapeutic inertia refers to the delay or failure to escalate treatment in patients who are not achieving adequate disease control and poses a challenge in the management of moderate-to-severe atopic dermatitis (AD). Despite the availability of conventional (CST) and advanced systemic therapies (AST) currently utilized for the treatment of moderate to severe AD, many patients do not achieve treatment success. However, the extent of this inadequacy in realworld clinical practice remains underexplored. Objectives: This study aims to evaluate the occurrence therapeutic inertia (assessed as non-escalation of therapy despite limited disease control) and the proportion of patients with moderate-to-severe AD who continue to show an inadequate response after receiving systemic therapies for a duration ranging from 3 to 12 months. Methods: We conducted a longitudinal analysis of patients with moderate-to-severe AD (vIGA-AD≥3) from the TARGET-DERM AD registry, including 3,457 participants from 39 centers in the U.S. and Canada. Eligible patients had documented outcomes at the initiation of systemic therapy and after 3 months up to 12 months of follow up. We assessed clinician- and patient-reported outcomes to identify the proportion of patients not meeting pre-defined targets based on expert consensus. An inadequate response was defined as not achieving a validated Investigator Global Assessment (vIGA-AD) score ≤2, a 50% improvement in Body Surface Area (BSA), and a ≥4-point reduction in the Worst Pruritus Numeric Rating Scale (WP-NRS). An optimal response was defined as a vIGA-AD score ≤1 (clear or almost clear skin), BSA ≤2%, and WP-NRS itch score of 0/1 (complete or almost complete skin resolution). Results: Out of 2,107 patients with moderate-to-severe AD, 445 met the inclusion criteria. The majority were adults (63.8%), female (62.0%), and Non-Hispanic White (45.4%), with an average age of 31 years. Most patients (88.8%) initiated treatment with AST, with dupilumab being the most common (86.5%). The mean vIGA-AD was 3.3 for AST and 3.6 for CST at initiation (P<0.01). At 6 months, 37% and 67% of AST-treated patients had inadequate responses in terms of skin clearance and itch outcomes, respectively, while 82% and 79% did not achieve optimal responses. At 12 months, these figures were approximately 30% and 66% for inadequate responses and 85% and 88% for not achieving optimal responses, respectively. CST-treated patients showed a similar trend. Conclusions: The study reveals a significant portion of moderate-to-severe AD patients fail to achieve adequate disease control with systemic therapies over 12 months, indicating a substantial presence of therapeutic inertia. These findings suggest a need for more proactive management strategies in AD treatment. [ABSTRACT FROM AUTHOR]

Background Patients hospitalized for coronavirus disease 2019 (COVID-19) may experience complications following hospitalization and require readmission. In this analysis, we estimated the rate and risk factors associated with COVID-19–related readmission and inpatient mortality. Methods In this retrospective cohort study, we used deidentified chargemaster data from 297 hospitals across 40 US states on patients hospitalized with COVID-19 from 15 February 2020 through 9 June 2020. Demographics, comorbidities, acute conditions, and clinical characteristics of first hospitalization are summarized. Multivariable logistic regression was used to measure risk factor associations with 30-day readmission and in-hospital mortality. Results Among 29 659 patients, 1070 (3.6%) were readmitted. Readmitted patients were more likely to have diabetes, hypertension, cardiovascular disease (CVD), or chronic kidney disease (CKD) vs those not readmitted (P  < .0001) and to present on first admission with acute kidney injury (15.6% vs 9.2%), congestive heart failure (6.4% vs 2.4%), or cardiomyopathy (2.1% vs 0.8%) (P  < .0001). Higher odds of readmission were observed in patients aged >60 vs 18–40 years (odds ratio [OR], 1.92; 95% confidence interval [CI], 1.48–2.50) and those admitted in the Northeast vs West (OR, 1.43; 95% CI, 1.14–1.79) or South (OR, 1.28; 95% CI, 1.11–1.49). Comorbidities including diabetes (OR, 1.34; 95% CI, 1.12–1.60), CVD (OR, 1.46; 95% CI, 1.23–1.72), CKD stage 1–5 (OR, 1.51; 95% CI, 1.25–1.81), and CKD stage 5 (OR, 2.27; 95% CI, 1.81–2.86) were associated with higher odds of readmission; 12.3% of readmitted patients died during second hospitalization. Conclusions Among this large US population of patients hospitalized with COVID-19, readmission was associated with certain comorbidities and acute conditions during first hospitalization. These findings may inform strategies to mitigate risks of readmission due to COVID-19 complications. [ABSTRACT FROM AUTHOR]

Nursing students rarely have the opportunity to witness nurse-to-nurse collaboration with nurses from differing specialties. Simulation can provide students with an opportunity to practice this important skill. In this simulation, students from a critical care course and students from a maternal/newborn course worked together to care for a pregnant client with COVID-19. The client’s condition required expertise from both an obstetrical nurse and a critical care nurse. Although the design of the simulation was aimed at collaboration, various other important observations and teaching moments were uncovered during the implementation of the simulation. [ABSTRACT FROM AUTHOR]

Background As coronavirus disease 2019 (COVID-19) disseminates throughout the United States, a better understanding of the patient characteristics associated with hospitalization, morbidity, and mortality in diverse geographic regions is essential. Methods Hospital chargemaster data on adult patients with COVID-19 admitted to 245 hospitals across 38 states between 15 February and 20 April 2020 were assessed. The clinical course from admission, through hospitalization, and to discharge or death was analyzed. Results A total of 11 721 patients were included (majority were >60 years of age [59.9%] and male [53.4%]). Comorbidities included hypertension (46.7%), diabetes (27.8%), cardiovascular disease (18.6%), obesity (16.1%), and chronic kidney disease (12.2%). Mechanical ventilation was required by 1967 patients (16.8%). Mortality among hospitalized patients was 21.4% and increased to 70.5% among those on mechanical ventilation. Male sex, older age, obesity, geographic region, and the presence of chronic kidney disease or a preexisting cardiovascular disease were associated with increased odds of mechanical ventilation. All aforementioned risk factors, with the exception of obesity, were associated with increased odds of death (all P values <.001). Many patients received investigational medications for treatment of COVID-19, including 48 patients on remdesivir and 4232 on hydroxychloroquine. Conclusions This large observational cohort describes the clinical course and identifies factors associated with the outcomes of hospitalized patients with COVID-19 across the United States. These data can inform strategies to prioritize prevention and treatment for this disease. [ABSTRACT FROM AUTHOR]

Severity of atopic dermatitis (AD) itch and lesions is associated with poor quality of life. However, there is limited evidence describing the combined impact of itch and skin severity on patient outcomes in AD. This study aims to assess the independent and combined effects of itch and skin severity on patient-reported symptoms and quality-of-life outcomes. The study included adult participants (age ≥18 years) with AD enrolled in TARGET-DERM AD, an observational, longitudinal study of more than 3158 participants across 43 academic/community centers in the USA and Canada. Itch severity was assessed by the Patient-Reported Outcome Measurement Information System Itch-Severity, specifically the item evaluating 'itch at its worst', a 0–10 numeric rating scale. A score of 0 or 1 was interpreted as no/minimal itch. Skin severity was assessed by the validated Investigators Global Assessment of AD (vIGA-AD), with a score of 0 or 1 representing clear/almost clear skin (vIGA-AD 0/1). The association of AD symptoms representing patient-reported clear/almost clear disease [Patient-Oriented Eczema Measure (POEM) 0–2] and no impact of AD on quality of life [Dermatology Life Quality Index (DLQI) 0/1] with itch and skin severity was assessed using descriptive statistics and logistic regression models that included main and interaction effects for itch and skin severity. Among adult participants (n = 1795; 59% female; 60% non-Hispanic White; mean age 44.5 years), vIGA-AD, POEM, Worst Itch and DLQI data at enrollment were available for 95% (1702), 44% (792), 43% (783) and 43% (783) of participants, respectively. The proportion reporting POEM 0–2 and DLQI 0/1 was highest among those with no/minimal worst itch (73% POEM 0–2; 72% DLQI 0/1) and clear/almost clear skin (46% POEM 0–2; 45% DLQI 0/1), with decreasing proportions observed at greater itch and skin severity levels. Among those with both no/minimal itch and clear/almost clear skin, 87.5% (42/48) and 95.8% (46/48) reported POEM 0–2 and DLQI 0/1, respectively. Logistic regression results suggest that no/minimal itch and clear/almost clear skin are significantly associated with POEM 0–2 and DLQI 0/1, though the interaction effect was not statistically significant in despite all models assessed. Relative to those who did not have either no/minimal itch or clear/almost clear skin, the odds ratio of reporting POEM 0–2 and DLQI 0/1 was highest among those with both no/minimal itch and clear/almost clear skin (82.9 for POEM 0–2; 35.4 for DLQI 0/1), followed by no/minimal itch only (15.9 for POEM 0–2; 10.5 for DLQI 0/1) and clear/almost clear skin only (5.9 for POEM 0–2; 3.8 for DLQI 0/1). Complete or almost complete relief of itch and skin lesions is associated with greater odds of achieving ideal states in PROs (POEM and DLQI) with itch relief exhibiting a relatively higher impact than skin clearance. These results underscore the importance of assessing and documenting both itch severity and skin clearance to support shared decision-making. Moreover, clearance of both itch and skin lesions should be considered when setting treatment goals in patients with AD. Future research should include analyzing discrepant data (e.g. patients with no/minimal itch, but some skin lesions) to more precisely identify which aspect drives the patient-reported outcomes. [ABSTRACT FROM AUTHOR]

Background: There is limited evidence that histologic remission improves outcomes in Crohn's disease (CD). We aimed to characterize a cohort of patients with CD in endoscopic remission and explore factors associated with subsequent loss of remission (LOR)., Methods: In total, 4474 patients were enrolled in TARGET-IBD, a longitudinal, observational cohort study. Patients with a normal steroid-free colonoscopy (index) were defined as "in endoscopic remission" and were followed for LOR, defined as presence of inflammation, erosion, ulceration, or stricturing on a subsequent colonoscopy or commencement of steroids. Histologic activity was dichotomized using standard of care reports for active inflammation. Unadjusted and multivariable-adjusted Cox proportional hazards regression models were used to estimate the hazard ratios (HRs) and 95% confidence intervals (CIs) of LOR in relation to independent variables., Results: Of 658 patients with CD with steroid-free endoscopic remission, the majority were female (57%), white (83%), non-Hispanic (93%); 20% had ileal and 20% isolated colonic disease. Inflammatory (B1) disease was the most common phenotype (43%). Of these 658 patients, 257 (39%) had histologic inflammation on index colonoscopy. Histologic inflammation at index colonoscopy was associated with nearly twice the LOR risk (HR 1.96, 95% CI: 1.50-2.57) with median time to relapse of 1.20 years. Biologic use at index was associated with lower LOR risk (monotherapy, HR 0.61, 95% CI: 0.45-0.82; combination therapy, HR 0.43, 95% CI: 0.28-0.66)., Conclusions: Active histologic inflammation despite endoscopic remission, and lack of biologic use were independently associated with risk of subsequent LOR, providing evidence that histologic remission may impart improved outcomes in patients with CD., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)