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RATIONALE: Observational studies report significant protective effect of antifibrotics on mortality among patients with idiopathic pulmonary fibrosis. Many of these studies, however, were subject to immortal time bias due to the mishandling of delayed antifibrotic initiation. OBJECTIVES: To evaluate the antifibrotic effect on mortality among patients with idiopathic pulmonary fibrosis using appropriate statistical methods that avoid immortal time bias. METHODS: Using a large administrative database, we identified 10,289 patients with idiopathic pulmonary fibrosis, of which 2,300 used antifibrotics. Treating delayed antifibrotic initiation as a time-dependent variable, three statistical methods were used to control baseline characteristics and avoid immortal time bias. Stratified analysis was performed for patients who initiated antifibrotics early and those who initiated treatment late. For comparison, methods that mishandle immortal time bias were performed. A simulation study was conducted to demonstrate the performance of these models in a wide range of scenarios. MEASUREMENTS AND MAIN RESULTS: All three statistical methods yielded non-significant results for the antifibrotic effect on mortality, with the stratified analysis for patients with early antifibrotic initiation suggesting evidence for reduced mortality risk: HR=0.89 (95% CI: 0.79-1.01, p=0.08) for all patients and HR=0.85 (95% CI: 0.73-0.98, p=0.03) for patients who were 65 years or older. Methods that mishandle immortal time bias demonstrated significantly lower mortality risk for antifibrotic users. Bias of these methods was evident in the simulation study, where appropriate methods performed well with little to no bias. CONCLUSIONS: Findings in this study did not confirm an association between antifibrotics and mortality, with a stratified analysis showing support for a potential treatment effect with early treatment initiation.
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INTRODUCTION: Interstitial lung disease encompasses a group of rare lung conditions causing inflammation and scarring of lung tissue. The typical method of monitoring disease activity is through pulmonary function tests performed in a hospital setting. However, accessing care can be difficult for rural patients due to numerous barriers. This study assesses the feasibility and acceptability of home spirometry telemonitoring using MIR-Spirometers and the patientMpower home-monitoring platform for rural patients with interstitial lung disease. METHODS: Unblinded, uncontrolled, prospective, multiple-methods study of the feasibility and utility of remote monitoring of 20 rural subjects with interstitial lung disease. Study assessments include adherence to twice weekly spirometry for 3 months in addition to mMRC dyspnea and EQ-5D-5L health-related quality of life questionnaires with each spirometry maneuver. Upon completion, subjects were encouraged to complete an 11-question satisfaction survey and participate in semi-structured qualitative interviews to further explore expectations and perceptions of rural patients to telehealth and remote patient monitoring. RESULTS: 19 subjects completed the 3-month study period. Adherence to twice weekly spirometry was mean 53% ± 38%, with participants on average performing 2.26 ± 1.69 maneuvers per week. The median (Range) number of maneuvers per week was 2.0 (0.0, 7.0). The majority of participants responded favorably to the patient satisfaction survey questions. Themes regarding barriers to access included: lack of local specialty care, distance to center with expertise, and time, distance, and high cost associated with travel. Remote monitoring was well perceived amongst subjects as a way to improve access and overcome barriers. CONCLUSIONS: Remote spirometry monitoring through web-based telehealth is acceptable and feasible for rural patients. Perceived benefits include overcoming access barriers like time, distance, and travel costs. However, cost, reimbursement, and internet access must be addressed before implementing it widely. Future studies are needed to ensure long-term feasibility and to compare outcomes with usual care.
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Enfermedades Pulmonares Intersticiales , Calidad de Vida , Humanos , Estudios Prospectivos , Estudios de Factibilidad , Espirometría , Enfermedades Pulmonares Intersticiales/diagnósticoRESUMEN
BACKGROUND: Rheumatoid arthritis (RA)-associated interstitial lung disease (ILD) is common in patients with RA and leads to significant morbidity and mortality. No randomized, placebo-controlled data are available that support the role of immunosuppression to treat RA-associated ILD, despite being widely used in clinical practice. RESEARCH QUESTION: How does immunosuppression impact pulmonary function trajectory in a multisite retrospective cohort of patients with RA-associated ILD? STUDY DESIGN AND METHODS: Patients with RA who started treatment for ILD with mycophenolate, azathioprine, or rituximab were identified retrospectively from five ILD centers. Change in lung function before and after treatment was analyzed using a linear spline mixed-effect model with random intercept. Prespecified secondary analyses examined the impact of radiologic pattern of ILD (ie, usual interstitial pneumonia [UIP] vs non-UIP) on treatment trajectory. RESULTS: Two hundred twelve patients were included in the analysis: 92 patients (43.4%) were treated with azathioprine, 77 patients (36.3%) were treated with mycophenolate mofetil, and 43 patients (20.3%) were treated with rituximab. In the combined analysis of all three agents, an improvement in FVC % predicted was found after 12 months of treatment compared with the potential 12-month response without treatment (+3.90%; P ≤ .001; 95% CI, 1.95-5.84). Diffusing capacity of the lungs for carbon monoxide (Dlco) % predicted also improved at 12 months (+4.53%; P ≤ .001; 95% CI, 2.12-6.94). Neither the UIP pattern of ILD nor choice of immunosuppressive agent significantly impacted the pulmonary function trajectory on immunosuppression. INTERPRETATION: Immunosuppression was associated with an improved trajectory in FVC and Dlco compared with the pretreatment pulmonary function trajectory. Prospective, randomized trials are required to validate these findings.
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Artritis Reumatoide , Fibrosis Pulmonar Idiopática , Enfermedades Pulmonares Intersticiales , Humanos , Artritis Reumatoide/complicaciones , Artritis Reumatoide/tratamiento farmacológico , Azatioprina/uso terapéutico , Terapia de Inmunosupresión , Inmunosupresores/uso terapéutico , Pulmón/diagnóstico por imagen , Enfermedades Pulmonares Intersticiales/tratamiento farmacológico , Enfermedades Pulmonares Intersticiales/etiología , Estudios Prospectivos , Estudios Retrospectivos , Rituximab/uso terapéutico , Resultado del Tratamiento , Capacidad VitalRESUMEN
Ophthalmic disease encountered in the intensive care unit (ICU) has a wide spectrum of prevalence and severity. Prolonged exposure of the cornea is common and preventable. Trauma, glaucoma, infection, vascular disease, and burns are among the potential causes of vision loss. Patients are predisposed to ocular complications by the ICU environment and critical illness itself. Critically ill patients require prioritization of life-sustaining interventions, and less emphasis is placed on ophthalmic disease, leading to missed opportunities for vision-saving intervention. It is therefore imperative for intensivists, nurses, and other providers to have an increased awareness and understanding of the broad range of ocular conditions potentially seen in the ICU.
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Oftalmopatías/etiología , Unidades de Cuidados Intensivos , Oftalmología , Enfermedades de la Córnea/epidemiología , Enfermedades de la Córnea/etiología , Enfermedades de la Córnea/prevención & control , Enfermedad Crítica , Oftalmopatías/epidemiología , Oftalmopatías/prevención & control , Oftalmopatías/terapia , Infecciones del Ojo/epidemiología , Infecciones del Ojo/etiología , Infecciones del Ojo/prevención & control , Humanos , Enfermedad Iatrogénica , Prevalencia , PronósticoRESUMEN
To better describe the outcomes of acute respiratory distress syndrome in mechanically ventilated patients with cirrhosis. DESIGN: Single-center, retrospective study of mechanically ventilated patients with cirrhosis between 2008 and 2015. SETTING: ICU at a large academic medical and transplant center. PATIENTS: One hundred eighty-one mechanically ventilated patients with cirrhosis. INTERVENTIONS: Demographic and clinical data were reviewed, and acute respiratory distress syndrome was identified per Berlin criteria. We compared demographic and clinical characteristics on ICU admission in patients with and without acute respiratory distress syndrome. The primary endpoint was hospital mortality (including discharge to hospice). Mortality risk was stratified by Chronic Liver Failure-Sequential Organ Failure Assessment and Model for End-Stage Liver Disease. MEASUREMENTS AND MAIN RESULTS: The mean age in 181 eligible patients was 53 ± 11 years; 67% were male; and 91% were Caucasian. In all, n = 35 (19%) of mechanically ventilated patients had acute respiratory distress syndrome. They were more frequently female (46% vs 30%; p = 0.08), with suspected infection (86% vs 53%; p < 0.001), and had higher mean Model for End-Stage Liver Disease (32 vs 24; p < 0.001) and Chronic Liver Failure-Sequential Organ Failure Assessment (15 vs 11; p < 0.001) than patients without acute respiratory distress syndrome. Hospital mortality was higher in patients with (40%) versus without (22%) acute respiratory distress syndrome (p = 0.03). In the risk-adjusted analysis (for Model for End-Stage Liver Disease, Chronic Liver Failure-Sequential Organ Failure Assessment and age), acute respiratory distress syndrome was not independently associated with hospital mortality (odds ratio, 0.80; CI, 0.3-2.5; p = 0.7). CONCLUSIONS: Acute respiratory distress syndrome is common in mechanically ventilated patients with cirrhosis but is not independently associated with increased mortality.