Angels Dancing on the Tip of a Needle: Interpreting Clinical Trials in Chronic Obstructive Pulmonary Disease.
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ABSTRACT:
SUBMITTER: Calverley P
PROVIDER: S-EPMC7605183 | biostudies-literature | 2020 Nov
REPOSITORIES: biostudies-literature
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Angels Dancing on the Tip of a Needle: Interpreting Clinical Trials in Chronic Obstructive Pulmonary Disease.
American journal of respiratory and critical care medicine 20201101 9
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Project description:Telehealth (TH) interventions with Chronic Obstructive Pulmonary Disease (COPD) management were introduced in the literature more than 20 years ago with different labeling, but there was no summary for the overall acceptance and dropout rates as well as associated variables. This review aims to summarize the acceptance and dropout rates used in TH interventions and identify to what extent clinical settings, sociodemographic factors, and intervention factors might impact the overall acceptance and completion rates of TH interventions. We conducted a systematic search up to April 2021 on CINAHL, PubMed, MEDLINE (Ovid), Cochrane, Web of Sciences, and Embase to retrieve randomized and non-randomized control trials that provide TH interventions alone or accompanied with other interventions to individuals with COPD. Twenty-seven studies met the inclusion criteria. Overall, the unweighted average of acceptance and dropout rates for all included studies were 80% and 19%, respectively. A meta-analysis on the pooled difference between the acceptance rates and dropout rates (weighted by the sample size) revealed a significant difference in acceptance and dropout rates among all TH interventions 51% (95% CI 49% to 52; p < 0.001) and 63% (95% CI 60% to 67; p < 0.001), respectively. Analysis revealed that acceptance and dropout rates can be impacted by trial-related, sociodemographic, and intervention-related variables. The most common reasons for dropouts were technical difficulties (33%), followed by complicated system (31%). Current TH COPD interventions have a pooled acceptance rate of 51%, but this is accompanied by a high dropout rate of 63%. Acceptance and dropout levels in TH clinical trials can be affected by sociodemographic and intervention-related factors. This knowledge enlightens designs for well-accepted future TH clinical trials. PROSPERO registration number CRD4201707854.
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| S-EPMC7462391 | biostudies-literature
Project description:ObjectiveOur goal is to determine short-term intraindividual biologic and measurement variability in spirometry of patients with a wide range of stable chronic obstructive pulmonary disease severity, using datasets from the National Emphysema Treatment Trial (NETT) and the Lung Health Study (LHS). This may be applied to determine criteria that can be used to assess a clinically meaningful change in spirometry.MethodsA total of 5,886 participants from the LHS and 1,215 participants from the NETT performed prebronchodilator spirometry during two baseline sessions. We analyzed varying criteria for absolute and percent change of FEV(1) and FVC to determine which criterion was met by 90% of the participants.ResultsThe mean +/- SD FEV(1) for the initial session was 2.64 +/- 0.60 L (75.1 +/- 8.8% predicted) for the LHS and 0.68 +/- 0.22 L (23.7 +/- 6.5% predicted) for the NETT. The mean +/- SD number of days between test sessions was 24.9 +/- 17.1 for the LHS and 85.7 +/- 21.7 for the NETT. As the degree of obstruction increased, the intersession percent difference of FEV(1) increased. However, the absolute difference between tests remained relatively constant despite the severity of obstruction (0.106 +/- 0.10 L). Over 90% of participants had an intersession FEV(1) difference of less than 225 ml irrespective of the severity of obstruction.ConclusionsAbsolute changes in FEV(1) rather than percent change should be used to determine whether patients with chronic obstructive pulmonary disease have improved or worsened between test sessions.
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Project description:Diaphragm muscles in Chronic Obstructive Pulmonary Disease (COPD) patients undergo an adaptive fast to slow transformation that includes cellular adaptations. This project studies the signaling mechanisms responsible for this transformation. Keywords: other
2003-07-16 | GSE475 | GEO
Project description:Chronic obstructive pulmonary disease (COPD) is a respiratory disease that has a major impact worldwide. The currently-available drugs mainly focus on relieving the symptoms of COPD patients. Novel regenerative therapeutic approaches have been investigated with the aim of repairing or replacing the injured functional structures of the respiratory system. We summarized the progress made by regenerative therapies for COPD by analyzing results from both pre-clinical studies and completed clinical trials. These approaches include the application of exogenous stem cells or small molecules to stimulate the regeneration by endogenous lung stem/progenitor cells. Exogenous mesenchymal stem cells (MSCs) have been reported to repair the structure and improve the function of the injured respiratory system in COPD models. However, the studies that used MSCs in patients with moderate-to-severe COPD patients did not lead to clear respiratory functional improvements. Exogenous human lung stem cells applied to cryo-injured (CI) lungs of mice have been shown to organize into human-like pulmonary structures, indicating a new property of stem cells that is potentially capable of curing COPD patients. Small molecules like retinoic acid has been shown to lead to regeneration and repair of the damaged lung structures in COPD mouse models probably by activation of endogenous lung stem/progenitor cells. However, retinoic acid or agonists of retinoic acid receptor administered to moderate or severe COPD patients did not improve the density and function of the damaged lung. These novel regenerative approaches have failed in preliminary clinical trials, possibly due to the advanced severity of the disease. Further work should be done to develop the current regenerative approaches for curing patients at different stages of COPD. We suggest that some modifications of the approach in the clinical studies may lead to more successful outcomes of regenerative therapy for COPD.
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Project description:Investigation of whole genome gene expression level changes of the dynamic gene profiling of peripheral blood mononuclear cells (PBMCs) from patients with AECOPD) on day1, 3 and 10, compared to the normal people and stable COPD patients. A five chip study using total RNA recovered from Peripheral Blood Mononuclear Cell of Peripheral Blood.Evaluating the dynamic gene profiling of peripheral blood mononuclear cells (PBMCs) from patients with AECOPD) on day1, 3 and 10 after the hospital admission, to compared with healthy controls or patients with stable COPD. Slides were scanned at 5 μm/pixel resolution using an Axon GenePix 4000B scanner (Molecular Devices Corporation) piloted by GenePix Pro 6.0 software (Axon). Scanned images (TIFF format) were then imported into NimbleScan software (version 2.5) for grid alignment and expression data analysis. Expression data were normalized through quantile normalization and the Robust Multichip Average (RMA) algorithm included in the NimbleScan software. The Probe level (*_norm_RMA.pair) files and Gene level (*_RMA.calls) files were generated after normalization.
2014-08-14 | E-GEOD-60399 | biostudies-arrayexpress
Project description:Pulmonary hypertension (PH) is a common complication of chronic obstructive pulmonary disease (COPD). Little is known about the prevalence and clinical profiles of patients with COPD-PH. We report the clinical characteristics, hemodynamic profiles, and prognosis in a large population of patients with COPD referred for right heart catheterization (RHC). We extracted data from all patients referred for RHC between 1997 and 2017 in Vanderbilt's deidentified medical record. PH was defined as mean pulmonary artery pressure >20 mmHg. Pre- and postcapillary PH were defined according to contemporary guidelines. COPD was identified using a validated rules-based algorithm requiring international classification of diseases codes relevant to COPD. We identified 6065 patients referred for RHC, of whom 1509 (24.9%) had COPD and 1213 had COPD and PH. Patients with COPD-PH had a higher prevalence of diabetes, atrial fibrillation, and heart failure compared with COPD without PH. Approximately 55% of patients with COPD-PH had elevated left ventricle (LV) filling pressure. Pulmonary function testing data from individuals with COPD-PH revealed subtype differences, with precapillary COPD-PH having lower diffusion capacity of the lungs for carbon monoxide (DLCO) values than the other COPD-PH subtypes. Patients with COPD-PH had significantly increased mortality compared with COPD alone (hazard ratio [HR]: 1.70, 95% confidence interval [CI]: 1.28-2.26) with the highest mortality among the combined pre- and postcapillary COPD-PH subgroup (HR: 2.39; 95% CI: 1.64-3.47). PH is common among patients with COPD referred for RHC. The etiology of PH in patients with COPD is often mixed due to multimorbidity and is associated with high mortality, which may have implications for risk factor management.
| S-EPMC9052979 | biostudies-literature
Project description:Investigation of whole genome gene expression level changes of the dynamic gene profiling of peripheral blood mononuclear cells (PBMCs) from patients with AECOPD) on day1, 3 and 10, compared to the normal people and stable COPD patients.
2014-08-14 | GSE60399 | GEO
Project description:Chronic obstructive pulmonary disease (COPD) Metagenome
| PRJNA647843 | ENA
Project description:RationaleFrailty represents an increased vulnerability to adverse health outcomes. The frailty phenotype conceptual model (three or more patient attributes of wasting, exhaustion, low activity, slowness, and weakness) is associated with increased morbidity and mortality in geriatric populations.ObjectivesOur objective was to describe the risks associated with frailty in patients with chronic obstructive pulmonary disease.MethodsData from the National Emphysema Treatment Trial (NETT) were retrospectively analyzed. The frailty phenotype conceptual model was operationalized as three or more frailty parameters (a body mass index decrease of ≥5% over 12 months, self-reported exhaustion, low 6-minute walk distance, or physical activity or respiratory muscle strength in the lowest quartile). Frail participants were compared with participants with two or fewer frailty parameters. Participants were followed starting 12 months after NETT randomization (to minimize surgical effect) for 24 months. Univariate, multivariate, Kaplan-Meier, and Cox proportional hazard analyses were performed, adjusting for treatment arm, age, modified Medical Research Council dyspnea scale, sex, and baseline forced expiratory volume in 1 second (FEV1). Multiple imputation was used for missing values.ResultsThe participants (N = 902) were predominantly white (94.5%) males (59.5%), with a median age of 67 years (interquartile range, 63-70 yr) and a median FEV1% predicted of 26 (interquartile range, 20-33). Six percent of the participants (95% confidence interval [CI], 4.5 to 7.6) were frail. The incidence rate of frailty was 6.4 per 100 person-years. Frail participants reported significantly worse disease-specific and overall quality of life by St. George's Respiratory Questionnaire total score (mean difference of 11.6; 95% CI, 7.6 to 15.6; P < 0.001), mental composite on Medical Outcomes Survey Short Form-36 (mean difference -6.8; 95% CI, -10.0 to -3.6; P < 0.001), and physical composite scores on Medical Outcomes Survey Short Form-36 (mean difference -16.7; 95% CI, -21.3 to -12.1; P = 0.001). Frail participants had an increased rate of hospitalization (adjusted hazard ratio, 1.6; 95% CI, 1.1 to 2.5; P = 0.02) and an adjusted increase in hospital use of 8.0 days (95% CI, 4.4 to 11.6; P < 0.001) compared with nonfrail participants. Frail participants had a higher mortality rate (adjusted hazard ratio, 1.4; 95% CI, 0.97 to 2.0; P = 0.07).ConclusionsAmong adults with chronic obstructive pulmonary disease, our measure of frailty (modified from the Fried frailty phenotype) was associated with incident and longer-duration hospitalization, and with poor quality of life.
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