Importance Pulmonary rehabilitation (PR) is the guideline-recommended most effective nonpharmacological therapy for people with chronic obstructive pulmonary disease (COPD) improving all outcomes. Despite the proven benefits, PR programs have low participant uptake, insufficient attendance, and high drop-out rates. Home programs are proposed as a solution: however, there is no randomized study to date in the US to inform remote programs.Objective To determine whether unsupervised home-based rehabilitation with technology and health coaching improve physical and emotional disease specific quality of life, daily physical activity, and self-management in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).Design, Setting, and Participants This multicenter, randomized, allocation-concealed, clinical trial enrolled 235 adult patients with COPD, of a planned sample size of 200, between March 2018 and December 2021 from two major health care systems in the US.Interventions Participants were randomized to unsupervised home-based rehabilitation with health coaching (N=116) or standard care (n = 119).Main Outcomes and Measures The primary outcome were disease-specific physical and emotional quality of life after the 12-week intervention. Prespecified secondary outcomes included measured daily physical activity, selfmanagement abilities, sleep, and symptoms of depression and anxiety.Results Among 307 patients who were randomized (mean age, 69 years;56% women) 235 (77%) completed the intervention and had measures. The was a significant difference in the intervention compared to the control group in the primary outcomes, daily physical activity, self-management, sleep, and depression scores: (adjusted Difference, Mean Change (95% CI) 0.47 points (0.27, 0.67) p<0.001, 0.48 (0.27, 0.69)p<0.001 for the physical and emotional quality of life respectively. Daily steps 655.83 (148.03, 1163.64) p<0.0116, selfmanagement 3.83 (1.85, 5.79) p<0.001, depression PHQ-9 -1.2 (-2.04, -0.35) p<0.0056 and total sleep time 54 min (6.74, 102.96) p<0.025 .Conclusions and Relevance Among patients with moderate to severe COPD, unsupervised home-based rehabilitation with monitoring technology and health coaching improved quality of life, daily physical activity, and self-management. This intervention represents an opportunity to increase the uptake of rehabilitation in COPD and to inform options of remote care that are now in increased demand in the context of the COVID-19 pandemic. (Figure Presented).
Background: The American College of Cardiology suggested physicians should only measure troponin and brain natriuretic peptide (BNP) if myocardial infarction or heart failure were suspected in people with COVID-19. We aimed to evaluate the use of biomarkers on admission to hospital and the impact on mortality and morbidity. Methods: Consecutive patients presenting with COVID-19(reverse transcription PCR positive) between Feb27-May20 2020 were included in this retrospective, observational, single-center study. Clinical information was collected on admission and during hospitalization by physicians and later analysed by specialist cardiology registrars. 1675 patients were PCR +ve with 1036 having a high sensitivity troponin T(hsTropT) on admission. 371(35.8%) patients were hs TropT negative(<15ng/L) and 664(64.1%) had evidence of myocardial injury on admission(hsTropT ≥15ng/L). Subsequently demographic details were compared, as well as primary outcomes of death, ICU admission and COVID severity. Secondary outcomes were ARDS, myocardial infarction (MI);comparison with other biomarkers: NT-proBNP, d-dimer, CRP,LDH and ferritin. Results: Demographic data revealed no significant increase in proportions of Black, Asian or ethnic minorities in the myocardial injury group, however, patients were older(74.9±13.5 v 54.7±13.7yrs;p <0.001) and had significantly more co-morbidities such as diabetes(37 v 13%), hypertension(34 v 29%), ischemic heart disease(16 v 2%), other cardiac conditions(59 v 5%), malignancy(11 v 1%), COPD(9 v 4%), CKD stage ≤3 (40 v 3%) (p <0.01). Mortality was significantly higher in the myocardial injury group, 302(45.5%) v 29(7.8%) p <0.001, as were secondary outcomes of critical COVID (47 v 19%;p<0.001), ARDS (20 v 4%;p<0.001), Type 1 MI (1.6 v 0.01%;p<0.01) and Type 2 MI (44 v 26%;p<0.001). Interestingly, ICU admission (19 v 23%;p=0.09), pulmonary embolism (11 v 6%;p=0.22), stroke (1.1 v 0.5%;p=0.05) did not reach significance. Analysis of bio-markers on admission (Fig 1.) demonstrated hs Trop T (AUC 0.75 CI 0.69-0.81) and NT-pro BNP (AUC 0.75 CI 0.69-0.81) had more sensitvity 83%;85% and specificty 52%;58%, respectively at predicting death than d-dimer, CRP, LDH and ferritin. Conclusion: Early detection of elevated hsTropT and NT-proBNP predicts mortality and morbidity in patient with COVID-19. Routine measurement of cardiac biomarkers should be considered in patients with COVID-19 at the time of hospital admission in order to optimise risk stratification and guide monitoring. (Figure Presented).
BACKGROUND In the primary analysis of the DRIVE-SHIFT trial, switching to doravirine/lamivudine/ tenofovir disoproxil fumarate (DOR/3TC/TDF) maintained suppression of HIV-1 through Week 48. Here we present long-term efficacy and safety outcomes through Week 144 of the DRIVE-SHIFT trial. METHODS This phase 3, randomized, open-label trial evaluated switching from a stable antiretroviral regimen to once-daily DOR/3TC/TDF in adults with HIV-1 suppressed for ≥6 months and no previous virologic failure. Participants switched at Day 1 (immediate-switch group [ISG]; n=447) or Week 24 (delayed-switch group [DSG]; n=209). Nine ISG participants who completed Week 48 but did not enter Extension-1 were excluded from Week 144 efficacy analyses. RESULTS At Week 144, HIV-1 RNA <50 copies/mL was maintained in 80.1% of the ISG (351/438) and 83.7% of the DSG (175/209), while 2.7% (12/438) and 4.8% (10/209), respectively, had HIV-1 RNA ≥50 copies/mL (FDA Snapshot). Protocol-defined virologic failure after switch occurred in 2.1% of ISG (9/438) and 3.3% of DSG (7/209); no viral resistance to doravirine was detected in four participants with samples available. Reductions in fasting lipids were observed at 24 weeks post-switch and maintained through Week 144. Mean weight change from switch to Week 144 was +1.4 kg for ISG and +1.2 kg for DSG. The most common adverse events were nasopharyngitis (16.2%), headache (12.3%) and diarrhea (9.1%). Overall, 4.1% discontinued due to adverse events, and no deaths occurred. CONCLUSIONS These results confirm that switching to once-daily DOR/3TC/TDF is a generally well-tolerated option for maintaining viral suppression in adults considering a change in therapy. REGISTRATION ClinicalTrials.gov NCT02397096.
Demographic and socioeconomic factors are recognized to contribute to disparities in healthcare outcomes. Originally, bronchiectasis was described in an all-white population in which racial disparity could not be identified. The U.S. Bronchiectasis Research Registry (BRR), a centralized database of adult patients with bronchiectasis and/or NTM from 18 clinical institutions across the U.S., was created to support the research of this condition. The aim of this study is to describe the racial composition of patients enrolled in the BRR and evaluate factors associated with healthcare disparities within manifestations of and/or the care delivered to this population. At the time of this study, 3,600 patients with bronchiectasis and/or NTM were enrolled in the BRR. Of those, 3,510 participants were included in these analyses The population was predominantly white (n=3143, 89.5%), followed by Hispanic (n=149, 4.3%), Asian (n=130, 3.7%) and Black (n=88, 2.5%) participants. Testing for cystic fibrosis, immunoglobulin deficiency, and mycobacteria was not different between races, but Black patients were tested less frequently for alpha-1 antitrypsin (A1AT) deficiency compared to other groups (P = 0.01). The four groups did not differ in the prevalence of Pseudomonas aeruginosa or Hemophilus influenzae. There was no statistically significant difference in use of high-frequency chest wall oscillation, pulmonary rehabilitation services, or suppressive macrolide treatment across the groups (P > 0.05). There is a disproportionately high percentage of white patients compared to Black and Hispanic patients in the BRR. However, we found an overall similarity of care of BRR patients, regardless of racial group.
OBJECTIVES:High rates of respiratory symptoms and chronic bronchitis (CB) are reported in people with HIV infection (PWH). We investigated the prevalence of respiratory symptoms and CB in PWH and HIV-negative people in the Pharmacokinetic and clinical Observations in PeoPle over fiftY (POPPY) study.METHODS:Assessment of respiratory symptoms and CB was undertaken using the modified form of the St. George's Respiratory Questionnaire for chronic obstructive pulmonary disease (COPD). Univariate (χ2 tests, Mann-Whitney U tests and Spearman's rank correlation) and multivariable (linear and logistic regression) analyses were performed to consider associations of respiratory symptoms with demographic, lifestyle and HIV-related parameters, and with depressive symptoms and quality of life.RESULTS:Among the 619 participants, respiratory Symptom scores were higher in older and younger PWH compared to older HIV-negative people, with median (interquartile range) scores of 17.7 (6.2, 39.5), 17.5 (0.9, 30.0) and 9.0 (0.9, 17.5), respectively (P = 0.0001); these differences remained significant after confounder adjustment. Sixty-three participants (10.2%) met the criteria for CB [44 (14.0%) older PWH, 14 (9.2%) younger PWH, and five (3.3%) older HIV-negative people; P = 0.002], with these differences also remaining after adjustment for confounding variables, particularly smoking status [older vs. younger PWH: odds ratio (OR) 4.48 (95% confidence interval (CI) 1.64, 12.30); P = 0.004; older PWH vs. HIV-negative people: OR 4.53 (95% CI 1.12, 18.28); P = 0.03]. Respiratory symptoms and CB were both associated with greater depressive symptom scores and poorer quality of life. No strong associations were reported between CB and immune function, HIV RNA or previous diagnosis of any AIDS event.CONCLUSIONS:Respiratory symptoms and CB are more common in PWH than in demographically and lifestyle-similar HIV-negative people and are associated with poorer mental health and quality of life.
The aims of the study were to describe the prevalence of obesity in the Pharmacokinetic and Clinical Observations in People over Fifty (POPPY) cohort, to identify demographic, clinical and HIV-specific factors associated with obesity, and to characterize the association between obesity and sociodemographic, clinical and HIV-specific factors and quality of life (QoL). A cross-sectional analysis was carried out of baseline data from the three groups [“older” people with HIV infection (PWH) aged ≥ 50 years, “younger” PWH aged < 50 years and HIV-negative controls aged ≥ 50 years] within the POPPY cohort. Obesity was defined as a body mass index (BMI) > 30 kg/m 2 . A total of 1361 subjects were included in the study, of whom 335 (24.6%) were obese. The prevalence of obesity was higher in controls (22.3%) than in older (16.8%) and younger (14.2%) PWH, with no differences between the two groups of PWH. Factors associated with obesity were older age, female gender, black African ethnicity and alcohol consumption. Recreational drug use and a higher current CD4 T-cell count (in PWH) were associated with lower and higher odds of being obese, respectively. The presence of obesity was associated with worse physical health QoL scores, higher odds of having cardiovascular disease, type 2 diabetes and hypertension, but lower odds of having osteopenia/osteoporosis, irrespective of HIV status. Despite a lower prevalence of obesity in PWH, specific subgroups (women, people of black African origin and older people) were more likely to be obese, and negative health consequences of obesity were evident, regardless of HIV status. Whether targeted preventive strategies can reduce the burden of obesity and its complications in PWH remains to be determined.