The Effects of a Video Intervention on Posthospitalization Pulmonary Rehabilitation Uptake. A Randomized Controlled Trial.

Rationale: Pulmonary rehabilitation (PR) after hospitalizations for exacerbations of chronic obstructive pulmonary disease (COPD) improves exercise capacity and health-related quality of life and reduces readmissions. However, posthospitalization PR uptake is low. To date, no trials of interventions to increase uptake have been conducted.Objectives: To study the effect of a codesigned education video as an adjunct to usual care on posthospitalization PR uptake.Methods: The present study was an assessor- and statistician-blinded randomized controlled trial with nested, qualitative interviews of participants in the intervention group. Participants hospitalized with COPD exacerbations were assigned 1:1 to receive either usual care (COPD discharge bundle including PR information leaflet) or usual care plus the codesigned education video delivered via a handheld tablet device at discharge. Randomization used minimization to balance age, sex, FEV1 % predicted, frailty, transport availability, and previous PR experience.Measurements and Main Results: The primary outcome was PR uptake within 28 days of hospital discharge. A total of 200 patients were recruited, and 196 were randomized (51% female, median FEV1% predicted, 36 [interquartile range, 27-48]). PR uptake was 41% and 34% in the usual care and intervention groups, respectively (P = 0.37), with no differences in secondary (PR referral and completion) or safety (readmissions and death) endpoints. A total of 6 of the 15 participants interviewed could not recall receiving the video.Conclusions: A codesigned education video delivered at hospital discharge did not improve posthospitalization PR uptake, referral, or completion.

A randomised controlled feasibility trial of Group Cognitive Behavioural Therapy for people with severe asthma.

OBJECTIVES: Evidence for the efficacy of Cognitive Behavioural Therapy (CBT) in asthma is developing but it is not known if this translates to benefits in severe asthma or if a group approach is acceptable to this patient group. This study aimed to assess the feasibility and acceptability of Group-CBT in severe asthma. METHOD: This was a two-centre, randomised controlled parallel group feasibility study. Eligible participants (patients with severe asthma and a clinically significant diagnosis of anxiety and/or depression - Hospital Anxiety and Depression Scale (HAD) score greater than 8 for the anxiety or depression sub-scale) received Group-CBT in weekly sessions for eight consecutive weeks and usual care or usual care only. Follow-up was for 16 weeks and end points were: Asthma Quality of Life Questionnaire, Asthma Control Questionnaire, HAD, Dyspnoea-12, EuroQual-5D and EuroQuol-VAS. RESULTS: 51 patients were randomised: 36% (51 out of 140) consent rate and attrition at week 16 was 12. Screening logs indicated that study take-up was influenced by patients living long distances from the treatment centre and inability to commit to the weekly demands of the programme. Drop-out was higher in Group-CBT compared due to inability to commit to the weekly programme because of poor health. Participants who contributed to focus group discussions reported that Group-CBT contributed to a better understanding of their illness and related approaches to anxiety management and acceptance of their asthma condition. Although weekly face-to-face sessions were challenging, this was the preferred method of delivery for these participants. CONCLUSIONS: This feasibility study shows that Group-CBT warrants further investigation as a potentially promising treatment option for patients with severe asthma. It has been possible but not easy to recruit and retain the sample. Options for a less demanding intervention schedule, such as less frequent face-to-face visits and the use of web-based interventions, require careful consideration.

Pulmonary rehabilitation following hospitalisation for acute exacerbation of COPD: referrals, uptake and adherence.

RATIONALE: Several randomised controlled trials support the provision of early pulmonary rehabilitation (PR) following hospitalisation for acute exacerbation of chronic obstructive pulmonary disease (AECOPD). However, there is little real-world data regarding uptake, adherence and completion rates. METHODS: An audit was conducted to prospectively document referral, uptake, adherence and completion rates for early post-hospitalisation outpatient PR in Northwest London over a 12-month period. RESULTS: Out of 448 hospital discharges for AECOPD, 90 referrals for post-hospitalisation PR were received. Only 43 patients received and completed PR (9.6% of all hospital discharges) despite a fully commissioned PR service. CONCLUSIONS: Despite the strong evidence base, there are poor referral and uptake rates for early outpatient PR following hospitalisation for AECOPD, with only a small proportion of the intended target population receiving this intervention.

Lp(a)-cholesterol is associated with HDL-cholesterol in overweight and obese African American children and is not an independent risk factor for CVD.

BACKGROUND: The role of lipoprotein (a) cholesterol {Lp(a)-C}as an additional and/or independent risk factor for cardiovascular disease (CVD) is not clear. We evaluated the associations between Lp(a)-C and other CVD risk factors including plasma lipoprotein concentrations and body fatness in overweight and obese African American children. METHODS: A cross-sectional analysis was carried out using data from a sample of 121 African American children aged 9-11 years with body mass index (BMI)'s greater than the 85th percentile. Body height, weight and waist circumference (WC) were measured. Fasting plasma concentrations of Lp(a)-C, total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), very low density lipoprotein cholesterol (VLDL-C), intermediate density lipoprotein cholesterol (IDL-C), low density lipoprotein cholesterol (LDL-C), and triacylglycerides (TAG) were analyzed using the vertical auto profile (VAP) cholesterol method. RESULTS: After adjusting for child age, gender, and pubertal status, Lp(a)-C was positively associated with both HDL-C and TC, and negatively associated with VLDL-C and TAG. Including BMIz and WC as additional covariates did not alter the direction of the relationships between Lp(a)-C and the other lipoproteins. Finally, after adjusting for the other plasma lipoproteins, Lp(a)-C remained strongly associated with HDL-C, whereas the associations of Lp(a)-C with the other lipoproteins were not significant when HDL-C was simultaneously included in the regression models. CONCLUSIONS: Lp(a)-C was positively associated with HDL-C and this association is not influenced by other lipoprotein subclasses or by the degree of obesity. We conclude that Lp(a) cholesterol is not an independent risk factor for CVD in African American children.

Identifying metabolic syndrome in African American children using fasting HOMA-IR in place of glucose.

INTRODUCTION: Metabolic syndrome (MetS) is increasing among young people. We compared the use of homeostasis model assessment of insulin resistance (HOMA-IR) with the use of fasting blood glucose to identify MetS in African American children. METHODS: We performed a cross-sectional analysis of data from a sample of 105 children (45 boys, 60 girls) aged 9 to 13 years with body mass indexes at or above the 85th percentile for age and sex. Waist circumference, blood pressure, and fasting levels of blood glucose, insulin, triglycerides, and high-density lipoprotein cholesterol were measured. RESULTS: We found that HOMA-IR is a stronger indicator of MetS in children than blood glucose. Using HOMA-IR as 1 of the 5 components, we found a 38% prevalence of MetS in this sample of African American children and the proportion of false negatives decreased from 94% with blood glucose alone to 13% with HOMA-IR. The prevalence of MetS was higher in obese than overweight children and higher among girls than boys. CONCLUSION: Using HOMA-IR was preferred to fasting blood glucose because insulin resistance was more significantly interrelated with the other 4 MetS components.

Insulin resistance is improved in overweight African American boys but not in girls following a one-year multidisciplinary community intervention program.

AIM: To assess potential for effectiveness, in a non-randomized pilot study, of a community-based lifestyle intervention program to reduce the risk for type 2 diabetes mellitus in overweight African American (AA) children. RESEARCH DESIGN: Sample of 165 9-11 year-old AA children with body mass index (BMI) >85th percentile were recruited from local recreational sites, schools and churches. Participants self-selected to attend one of two study sites, blinded to the specifics of the intervention administered at each site. The intervention group received a programmatically focused 2-week summer camp with once-a-week community-based exercise, nutrition, and behavioral modification sessions, and their families were invited to monthly nutrition educational sessions. Control group participants received a 2-week conventional YMCA summer camp and their families received nutrition and physical activity education material through the mail. Baseline assessment and 1-year follow-up were conducted in collaboration with the YMCA of the East Bay and Children's Hospital Oakland, CA, with 109 participants (66%) having pre/post data. RESULTS: After one-year of intervention, treatment boys showed a drop in homeostasis model assessment of insulin-resistance (HOMA-IR) (-0.58 vs +0.17; p = 0.003), fasting glucose (Gf, mg/dL) (mean change: -2.9 vs +0.4; p = 0.126) and fasting insulin (If, microU/mL) (-2.2 vs +0.7; p = 0.009) compared to control boys, after accounting for baseline differences and pubertal stage of the child. Treatment girls had similar changes to the control girls in HOMA-IR (-0.02 vs -0.17; p = 0.66), Gr (-0.3 vs +1.4; p = 0.29) and If (+0.03 vs +0.17; p = 0.57). CONCLUSION: After one year, this community-based intervention program effectively improved insulin resistance and thus reduced risk for type 2 diabetes mellitus in overweight AA boys but did not change the risk in girls compared to control children.

Accuracy of self-assessed Tanner staging against hormonal assessment of sexual maturation in overweight African-American children.

AIM: To evaluate the accuracy of self-reported Tanner (SRT) staging against a proxy method of physician's assessment of sexual maturation, using pubertal hormones in overweight African-American (AA) children. METHODS: Cross-sectional data from 196 children (113 girls, 83 boys) aged 9-11 years, who were 'overweight' (>85th and <95th percentile for age- and gender-matched BMI; n = 43) or 'obese' (>95th percentile; n = 153) were used. Children assessed their breast or genital and pubic hair development using standardized Tanner drawings representing different stages of sexual maturity. SRT data were compared to pubertal stage assessed by measuring fasting serum concentrations of luteinizing hormone (LH) in boys, and LH and estradiol (E2) in girls, which were used to stage children into pubertal stages 1-5. RESULTS: SRT stages of genital and pubic hair assessments in boys, and breast and pubic hair assessments in girls, yielded 15-20% concordance (kappa statistic = 0.02-0.12) compared to their hormone-derived pubertal stages. CONCLUSIONS: Among overweight AA 9-11 year-old children, self-assessment of Tanner staging did not accurately assess their pubertal development when compared to a hormone-derived pubertal assessment method.

Effect of ambulatory oxygen on quality of life for patients with fibrotic lung disease (AmbOx): a prospective, open-label, mixed-method, crossover randomised controlled trial.

BACKGROUND: In fibrotic interstitial lung diseases, exertional breathlessness is strongly linked to health-related quality of life (HRQOL). Breathlessness is often associated with oxygen desaturation, but few data about the use of ambulatory oxygen in patients with fibrotic interstitial lung disease are available. We aimed to assess the effects of ambulatory oxygen on HRQOL in patients with interstitial lung disease with isolated exertional hypoxia. METHODS: AmbOx was a prospective, open-label, mixed-method, crossover randomised controlled clinical trial done at three centres for interstitial lung disease in the UK. Eligible patients were aged 18 years or older, had fibrotic interstitial lung disease, were not hypoxic at rest but had a fall in transcutaneous arterial oxygen saturation to 88% or less on a screening visit 6-min walk test (6MWT), and had self-reported stable respiratory symptoms in the previous 2 weeks. Participants were randomly assigned (1:1) to either oxygen treatment or no oxygen treatment for 2 weeks, followed by crossover for another 2 weeks. Randomisation was by a computer-generated sequence of treatments randomly permuted in blocks of constant size (fixed size of ten). The primary outcome, which was assessed by intention to treat, was the change in total score on the King's Brief Interstitial Lung Disease questionnaire (K-BILD) after 2 weeks on oxygen compared with 2 weeks of no treatment. General linear models with treatment sequence as a fixed effect were used for analysis. Patient views were explored through semi-structured topic-guided interviews in a subgroup of participants. This study was registered with ClinicalTrials.gov, number NCT02286063, and is closed to new participants with all follow-up completed. FINDINGS: Between Sept 10, 2014, and Oct 5, 2016, 84 patients were randomly assigned, 41 randomised to ambulatory oxygen first and 43 to no oxygen. 76 participants completed the trial. Compared with no oxygen, ambulatory oxygen was associated with significant improvements in total K-BILD scores (mean 55·5 [SD 13·8] on oxygen vs 51·8 [13·6] on no oxygen, mean difference adjusted for order of treatment 3·7 [95% CI 1·8 to 5·6]; p<0·0001), and scores in breathlessness and activity (mean difference 8·6 [95% CI 4·7 to 12·5]; p<0·0001) and chest symptoms (7·6 [1·9 to 13·2]; p=0·009) subdomains. However, the effect on the psychological subdomain was not significant (2·4 [-0·6 to 5·5]; p=0·12). The most common adverse events were upper respiratory tract infections (three in the oxygen group and one in the no-treatment group). Five serious adverse events, including two deaths (one in each group) occurred, but none were considered to be related to treatment. INTERPRETATION: Ambulatory oxygen seemed to be associated with improved HRQOL in patients with interstitial lung disease with isolated exertional hypoxia and could be an effective intervention in this patient group, who have few therapeutic options. However, further studies are needed to confirm this finding. FUNDING: UK National Institute for Health Research.

A systematic review of psychological interventions for children with asthma.

AIM: Psychological factors may influence the symptoms and management of asthma in children in many ways. It is, therefore, suggested that psychological interventions may be appropriate for this population. This paper reports a systematic review assessing the efficacy of psychological interventions in improving health outcomes for children with asthma. METHODOLOGY: A review of Randomized Controlled Trials (RCT) was designed. RCTs assessing the effects of a psychological intervention in child participants were included in the review. Outcome measures included healthcare utilization, lung function, asthma symptoms, and psychological health status. The search was conducted until April 2005. RESULTS: Twelve studies, involving 588 children, were included in the review; however, study quality was poor and sample sizes were frequently small. A meta-analysis was performed on two studies, examining the effects of relaxation therapy on PEFR which favored the treatment group (SD 0.82, CI 0.41-1.24). No other meta-analysis could be performed due to the diversity of interventions and the outcomes assessed. In addition, many studies reported insufficient data. CONCLUSIONS: This review was unable to draw firm conclusions for the role of psychological interventions for children with asthma. We recommend that valid outcome measures for evaluating the effectiveness of psychological interventions for children with asthma need to address adjustment to and coping with asthma, as well as other psychological indicators. The absence of an adequate evidence base is demonstrated, highlighting the need for well-conducted RCTs in this area.

Psychological interventions for adults with asthma: a systematic review.

AIM: The purpose of this study was to conduct a systematic review of randomized controlled trials where the efficacy of psychological interventions in modifying health and behavioural outcomes for adults with asthma was investigated. METHOD: A review of randomized controlled trials was designed. The literature search was conducted until May 2005. RESULTS: Fourteen studies, involving 617 adults, were included in the review. The use of 'as needed' medications was reduced by relaxation therapy (OR 4.47, CI 1.22-16.44), quality of life, measured using the Asthma Quality of Life Questionnaire, showed a positive effect following cognitive behavioural therapy (WMD 0.71, CI 0.23-1.19), and peak expiratory flow outcome data indicated a significant difference in favour of bio-feedback therapy (SMD 0.66, CI 0.09-1.23). CONCLUSIONS: Some promising results did emerge from meta-analyses performed. However, due to heterogeneity and the low quality of included studies, this review was unable to draw firm conclusions for the role of psychological interventions in asthma. We recommend that larger and well-conducted randomized trials use valid outcome measures to evaluate the effectiveness of psychological interventions for adults with asthma.

Ambulatory oxygen in fibrotic lung disease (AmbOx): study protocol for a randomised controlled trial.

BACKGROUND: Fibrotic interstitial lung diseases (ILDs) are chronic and often progressive conditions resulting in substantial morbidity and mortality. Shortness of breath, a symptom often linked to oxygen desaturation on exertion, is tightly linked to worsening quality of life in these patients. Although ambulatory oxygen is used empirically in their treatment, there are no ILD-specific guidelines on its use. To our knowledge, no studies are available on the effects of ambulatory oxygen on day-to-day life in patients with ILD. METHODS/DESIGN: Ambulatory oxygen in fibrotic lung disease (AmbOx) is a multicentre, randomised controlled crossover trial (RCT) funded by the Research for Patient Benefit Programme of the National Institute for Health Research. The trial will compare ambulatory oxygen used during daily activities with no ambulatory oxygen in patients with fibrotic lung disease whose oxygen saturation (SaO2) is ≥94% at rest, but drops to ≤88% on a 6-min Walk Test. The randomised controlled trial (RCT) will evaluate the effects on health status (measured by the King's Brief ILD Questionnaire: K-BILD) of ambulatory oxygen used at home, at an optimal flow rate determined by titration at screening visit, and administered for a 2-week period, compared to 2 weeks off oxygen. Key secondary outcomes will include breathlessness on activity scores, as measured by the University of California San Diego Shortness of Breath Questionnaire, global patient assessment of change scores, as well as quality of life scores (St George's Respiratory Questionnaire), anxiety and depression scores (Hospital Anxiety and Depression Scale), activity markers measured by SenseWear Armbands, pulse oximetry measurements, patient-reported daily activities, patient- and oxygen company-reported oxygen cylinder use. The study also includes a qualitative component and will explore in interviews patients' experiences of the use of a portable oxygen supply and trial participation in a subgroup of 20 patients and carers. DISCUSSION: This is the first RCT of the effects of ambulatory oxygen during daily life on health status and breathlessness in fibrotic lung disease. The results generated should provide the basis for setting up ILD-specific guidelines for the use of ambulatory oxygen. TRIAL REGISTRATION: National Clinical Trials Registry, identifier: NCT02286063 . Registered on 8 October 2014 (retrospectively registered).

Influence of body dissatisfaction on 1-year change in nutrient intake of overweight and obese inner-city African American children.

This analysis aimed to examine the relationship of baseline body dissatisfaction with 1-year change in nutrient intake of inner-city, overweight and obese, African American children. This is a secondary analysis of 1-year pre-post data available for a convenience sample of 88 children. After adjusting for baseline intake of dietary variables and intervention group status, baseline body dissatisfaction was associated with 1-year increases in intake of energy, and all macronutrients in girls, but not in boys. These relationships were not substantially altered after adjusting for baseline BMIz and global self-worth. After including all adjustment factors, increasing baseline body dissatisfaction in girls was associated with 1-year increased intake of total energy, total sugars, total fat, discretionary fat, and total carbohydrates. This analysis suggests that, in girls but not necessarily in boys, body dissatisfaction might need to be targeted during interventions that aim to improve nutrient intake.

Diet induced obesity increases the risk of colonic tumorigenesis in mice.

A large body of epidemiological data indicates that obesity increases the risk of colon cancer in humans. There are limited studies using rodent models where the relationship between obesity and colon cancer has been studied. In this study, wild-type diet-induced obese (DIO) mice and lean wild-type controls were used to investigate the influence of obesity on the risk of colon cancer. We hypothesized that the obese phenotype would exhibit increased colonic tumorigenesis. Colon cancer was chemically induced by injecting the mice with azoxymethane (AOM) at levels that we experimentally determined to result in equivalent AOM concentrations in circulating blood. Risk of colon cancer was assessed via microscopic examination of entire colons for aberrant crypts, aberrant crypt foci and proliferation levels. The DIO mice were found to have significantly more aberrant crypts and aberrant crypt foci as well as increased proliferation of colonocytes per mouse compared to wild-type control mice, supporting the epidemiological data that obesity increases the risk of colonic tumorigenesis.

Risk of colonic cancer is not higher in the obese Lep(ob) mouse model compared to lean littermates.

Epidemiological data suggest that obesity increases the risk of colorectal cancer in humans. Given that diet-induced obesity mouse models verified the epidemiological data, the present study aimed to determine whether obese C57BL/6J-Lep(ob) male mice (a different obesity in vivo model) were at greater risk of colonic cancer than their lean male littermates. Risk of colonic tumorigenesis was assessed by numbers of aberrant crypts, aberrant crypt foci and colonic tumors. Proliferation of the colonic epithelia was assessed histochemically following administration of BrdU. Availability of the procarcinogen, azoxymethane (AOM) to target tissues was assessed by quantifying via HPLC plasma AOM concentrations during the 60 min period following AOM injection. When obese and lean mice were injected with azoxymethane (AOM) at doses calculated to provide equivalent AOM levels per kg lean body mass, obese animals had significantly fewer aberrant crypts/colon and fewer aberrant crypt foci/colon than the lean animals. Tumors were identified in the colonic mucosa of lean (4 tumors in 14 mice) but not obese (0 tumors in 15 mice) mice. Colonic cell proliferation was not significantly different for obese and lean mice. Because these results were unexpected, plasma AOM concentrations were measured and were found to be lower in the obese than lean mice. When plasma AOM levels were comparable for the lean and obese mice, the Lep(ob) mice continued to have significantly fewer aberrant crypt foci/colon than the lean mice, but differences were not statistically different for aberrant crypts/colon. Interestingly, obese Lep(ob) mice did not exhibit increased risk of colonic cancer as expected. Instead, Lep(ob) mice exhibited equivalent or lower risk of colon cancer when compared to the lean group. These results taken together with in vivo results from diet-induced obesity studies, imply that leptin may be responsible for the increased risk of colon cancer associated with obesity.

Use of HbA(1C) testing to diagnose pre-diabetes in high risk African American children: a comparison with fasting glucose and HOMA-IR.

OBJECTIVE: This study aimed to compare the discriminating power of HbA(1C) with other pre-diabetes diagnostic tests specifically in high-risk African American children. RESEARCH DESIGN AND METHODS: A cross-sectional analysis was performed on a sample of 172 children (70 boys and 102 girls) aged 9-11 years with BMI's above the 85th percentile. Fasting glucose, insulin and HbA(1C) were analyzed from the plasma samples. RESULTS: Of the 172 participants included in this analysis, 21 (12.2%) had HbA(1C) concentrations above the cutoff of 5.7 used to identify pre-diabetes. None (0%) of these 21 participants, however, were observed to have a glucose concentration above the pre-diabetes cutoff of 110 mg/dl, and only 13 of 21 participants had HOMA-IR above the pre-diabetes cutoff of 2.5. When compared to the previously identified glucose cutoff of 110 mg/dl and HOMA-IR cutoff of 2.5 for pre-diabetes, HbA(1C) showed high specificity (88 and 93%, respectively) but very low sensitivity (0 and 21%, respectively). Glucose, insulin and HOMA-IR were significantly interrelated, but HbA(1C) was not significantly correlated with these biochemical prediabetes assessment variables, nor with anthropometric (BMIz, WC) risk factors. CONCLUSION: Our results suggest that HbA(1C) had poor discrimination power to identify prediabetes in overweight and obese 9- to 11-year-old African American children. Future studies are recommended to compare the feasibility, sensitivity and predictive power of different screening tests currently recommended to avoid inadequacy when screening for prediabetes and diabetes.

One-year change in energy and macronutrient intakes of overweight and obese inner-city African American children: effect of community-based Taking Action Together type 2 diabetes prevention program.

Taking Action Together (TAT) was a controlled community-based intervention protocol developed to reduce risk of T2DM among low-income, high BMI, 9-10 year old African American children. A secondary hypothesis of this study was that there would be greater improvements in the treatment group in dietary intakes and physical activity. To evaluate the primary study objectives, multiple linear regression models were employed, with 1 year change in dietary variables as dependent variables. Intervention group status was the independent variable of interest and BMIz was included as a covariate in all analyses to adjust for group differences in baseline obesity status of the children. The findings from this analysis suggest that 1 year change in dietary intakes in boys was associated with group intervention status, with boys in the treatment group reducing their intakes of energy and fat to a significantly greater extent than boys in the control group. Differences in energy intakes were not significant, however, for girls. Based on the differences in gender response to our comprehensive TAT intervention, we conclude that interventions designed for and delivered only to African American girls might be more successful than those delivered in mixed gender settings.

Dietary intakes of urban, high body mass index, African American children: family and child dietary attributes predict child intakes.

OBJECTIVE: To identify family and child nutrition and dietary attributes related to children's dietary intakes. DESIGN: African American children (ages 8-11 years, n = 156), body mass index > 85th percentile, from urban, low-income neighborhoods. Baseline, cross-sectional data collected as part of an ongoing diabetes prevention intervention. Dietary intakes were collected by 3-day food diary to assess total energy, percent fat, discretionary fat, added sugar, whole grains, vegetables, fruit, meat, and dairy. Questionnaires on nutrition and dietary attributes administered to children and parents were used to develop 5 diet-related indices: child knowledge, child preferences, child snack habits, child beverage habits, and family food habits. RESULTS: A higher child nutrition knowledge score was significantly related to a lower starchy vegetable intake. Higher scores on the child snack habits index were significantly related to higher intakes of fruit, total fruits and vegetables, total fruits and nonstarchy vegetables, and to lower intakes of added sugars. A higher score on the family food habits index was significantly related to lower intakes of total energy and discretionary fat. CONCLUSIONS AND IMPLICATIONS: Targeting both child and family food and nutrition attributes may be used to promote more healthful eating among urban, low-income, overweight African American children.