Background To improve methods for long-term weight management, the Weight Loss Maintenance (WLM) trial, a four-center randomized trial, was conducted to compare alternative strategies for maintaining ...weight loss over a 30-month period. This paper describes methods and results for the initial 6-month weight-loss program (Phase I). Methods Eligible adults were aged ≥25, overweight or obese (BMI=25–45 kg/m2 ), and on medications for hypertension and/or dyslipidemia. Anthropomorphic, demographic, and psychosocial measures were collected at baseline and 6 months. Participants ( n =1685) attended 20 weekly group sessions to encourage calorie restriction, moderate-intensity physical activity, and the DASH (dietary approaches to stop hypertension) dietary pattern. Weight-loss predictors with missing data were replaced by multiple imputation. Results Participants were 44% African American and 67% women; 79% were obese (BMI≥30), 87% were taking anti-hypertensive medications, and 38% were taking antidyslipidemia medications. Participants attended an average of 72% of 20 group sessions. They self-reported 117 minutes of moderate-intensity physical activity per week, kept 3.7 daily food records per week, and consumed 2.9 servings of fruits and vegetables per day. The Phase-I follow-up rate was 92%. Mean (SD) weight change was −5.8 kg (4.4), and 69% lost at least 4 kg. All race–gender subgroups lost substantial weight: African-American men (−5.4 kg ± 7.7); African-American women (−4.1 kg ± 2.9); non–African-American men (−8.5 kg ± 12.9); and non–African-American women (−5.8 kg ± 6.1). Behavioral measures (e.g., diet records and physical activity) accounted for most of the weight-loss variation, although the association between behavioral measures and weight loss differed by race and gender groups. Conclusions The WLM behavioral intervention successfully achieved clinically significant short-term weight loss in a diverse population of high-risk patients.
Although caries is prevalent in adults, investigators have tested few preventive therapies in adult populations. In a randomized controlled trial, the authors evaluated the effectiveness of xylitol ...lozenges in preventing caries in adults at elevated risk of developing caries.
The Xylitol for Adult Caries Trial (X-ACT) was a three-site placebo-controlled randomized trial. Participants (n = 691) aged 21 through 80 years consumed five 1.0-gram xylitol or placebo lozenges daily for 33 months. They underwent clinical examinations at baseline and at 12, 24 and 33 months.
Xylitol lozenges reduced the caries increment 10 percent. This reduction, which represented less than one-third of a surface per year, was not statistically significant. There was no indication of a dose-response effect.
Daily use of xylitol lozenges did not result in a statistically or clinically significant reduction in 33-month caries increment among adults at an elevated risk of developing caries.
These results suggest that xylitol used as a supplement in adults does not reduce their caries experience significantly.
Summary Background Chronic obstructive pulmonary disease (COPD) is a growing cause of morbidity and mortality worldwide, and accurate estimates of the prevalence of this disease are needed to ...anticipate the future burden of COPD, target key risk factors, and plan for providing COPD-related health services. We aimed to measure the prevalence of COPD and its risk factors and investigate variation across countries by age, sex, and smoking status. Methods Participants from 12 sites (n=9425) completed postbronchodilator spirometry testing plus questionnaires about respiratory symptoms, health status, and exposure to COPD risk factors. COPD prevalence estimates based on the Global Initiative for Chronic Obstructive Lung Disease staging criteria were adjusted for the target population. Logistic regression was used to estimate adjusted odds ratios (ORs) for COPD associated with 10-year age increments and 10-pack-year (defined as the number of cigarettes smoked per day divided by 20 and multiplied by the number of years that the participant smoked) increments. Meta-analyses provided pooled estimates for these risk factors. Findings The prevalence of stage II or higher COPD was 10·1% (SE 4·8) overall, 11·8% (7·9) for men, and 8·5% (5·8) for women. The ORs for 10-year age increments were much the same across sites and for women and men. The overall pooled estimate was 1·94 (95% CI 1·80–2·10) per 10-year increment. Site-specific pack-year ORs varied significantly in women (pooled OR=1·28, 95% CI 1·15–1·42, p=0·012), but not in men (1·16, 1·12–1·21, p=0·743). Interpretation This worldwide study showed higher levels and more advanced staging of spirometrically confirmed COPD than have typically been reported. However, although age and smoking are strong contributors to COPD, they do not fully explain variations in disease prevalence—other factors also seem to be important. Although smoking cessation is becoming an increasingly urgent objective for an ageing worldwide population, a better understanding of other factors that contribute to COPD is crucial to assist local public-health officials in developing the best possible primary and secondary prevention policies for their regions.
Asthma outcomes: Quality of life Wilson, Sandra R., PhD; Rand, Cynthia S., PhD; Cabana, Michael D., MD, MPH ...
Journal of allergy and clinical immunology,
03/2012, Letnik:
129, Številka:
3
Journal Article
Recenzirano
Odprti dostop
Background “Asthma-related quality of life” (QOL) refers to the perceived impact that asthma has on the patient’s QOL. Objective National Institutes of Health institutes and other federal agencies ...convened an expert group to recommend standardized measures of the impact of asthma on QOL for use in future asthma clinical research. Methods We reviewed published documentation regarding the development and psychometric evaluation; clinical research use since 2000; and extent to which the content of each existing QOL instrument provides a unique, reliable, and valid assessment of the intended construct. We classified instruments as core (required in future studies), supplemental (used according to the study’s aims and standardized), or emerging (requiring validation and standardization). This work was discussed at an National Institutes of Health-organized workshop convened in March 2010 and finalized in September 2011. Results Eleven instruments for adults and 6 for children were identified for review. None qualified as core instruments because they predominantly measured indicators of asthma control (symptoms and/or functional status); failed to provide a distinct, reliable score measuring all key dimensions of the intended construct; and/or lacked adequate psychometric data. Conclusions In the absence of existing instruments that meet the stated criteria, currently available instruments are classified as either supplemental or emerging. Research is strongly recommended to develop and evaluate instruments that provide a distinct, reliable measure of the patient’s perception of the impact of asthma on all of the key dimensions of QOL, an important outcome that is not captured in other outcome measures.
Background Excess adiposity and dietary factors may be important determinants of urinary albumin excretion (UAE). Study Design Observational analysis of PREMIER, a randomized trial designed to lower ...blood pressure using behavioral interventions (counseling on weight loss, healthy diet, and exercise). Setting & Participants 481 participants with normal kidney function who provided adequate 24-hour urine collections at baseline and 6 months. Predictors Change in waist circumference; 24-hour urine sodium, potassium, and phosphorus excretion; and protein intake estimated from urea nitrogen. Outcomes & Measurements The primary outcome was change in log-transformed 24-hour UAE over 6 months. Results After 6 months, the proportion of individuals with UAE ≥10 mg/d decreased from 18.7% to 12.7% ( P < 0.001). Changes in mean waist circumference (−4.2 ± 6.6 SD cm), 24-hour excretion of sodium (−28.2 ± 71.7 mmol/d), potassium (+8.4 ± 27.8 mmol/d), phosphorus (−27.7 ± 314.1 mg/d), and protein intake (−1.7 ± 19.4 g/d) were observed. After adjustment for relevant covariates, the following variables were associated significantly with reduction in ln(UAE) in separate models: decrease in waist circumference ( P = 0.001), decrease in 24-hour urine phosphorus excretion ( P < 0.001), and decrease in protein intake ( P = 0.01). In a multivariable model including these 3 predictors, decreases in waist circumference ( P = 0.002) and 24-hour urine phosphorus excretion ( P = 0.03), but not change in protein intake ( P = 0.5), remained associated significantly with reduction in ln(UAE). These associations remained significant even after adjustment for changes in blood pressure and insulin resistance. Baseline UAE and metabolic syndrome modified the relationship of waist circumference with ln(UAE); specifically, individuals with higher UAE and baseline metabolic syndrome experienced greater reductions in ln(UAE) from decreases in waist circumference. Limitations Observational study with potential for confounding. Conclusions In adults with normal kidney function, decreases in waist circumference and 24-hour urine phosphorus excretion are associated with reductions in UAE. These findings support the rationale for clinical trials to determine whether reducing dietary phosphorus intake or waist circumference could prevent chronic kidney disease or slow its progression.
Mediators of asthma outcomes Rand, Cynthia S., PhD; Wright, Rosalind J., MD, MPH; Cabana, Michael D., MD, MPH ...
Journal of allergy and clinical immunology,
03/2012, Letnik:
129, Številka:
3
Journal Article
Recenzirano
Odprti dostop
Background Patient adherence, the level of asthma self-management skills, exposure to stress, and depression can have considerable influence on a wide range of asthma outcomes and thus are considered ...asthma outcome mediators. Objective National Institutes of Health institutes and other federal agencies convened an expert group to recommend standardized measures for 7 domains of asthma clinical research outcomes measures. Although the review of mediators of these outcomes was not within the scope of any specific outcome topic, a brief summary is presented so that researchers might consider potential mediators. Methods We prepared a summary of key mediators of asthma outcomes based on expertise and knowledge of the literature. Results The rationale for including measures of adherence, self-management skills, and exposures to stress in asthma clinical research is presented, along with a brief review of instruments for collecting this information from clinical research participants. Conclusions Appropriate measurement of adherence, self-management skills, and exposures to stress will enhance characterization of study participants and provide information about the potential impact these factors can have on mediating the effects of treatment interventions.
Abstract Objectives Preplanned economic analysis of a pragmatic trial using electronic-medical-record–linked interactive voice recognition (IVR) reminders for enhancing adherence to cardiovascular ...medications (i.e., statins, angiotensin-converting enzyme inhibitors ACEIs, and angiotensin receptor blockers ARBs). Methods Three groups, usual care (UC), IVR, and IVR plus educational materials (IVR+), with 21,752 suboptimally adherent patients underwent follow-up for 9.6 months on average. Costs to implement and deliver the intervention (from a payer perspective) were tracked during the trial. Medical care costs and outcomes were ascertained using electronic medical records. Results Per-patient intervention costs ranged from $9 to $17 for IVR and from $36 to $47 for IVR+. For ACEI/ARB, the incremental cost-effectiveness ratio for each percent adherence increase was about 3 times higher with IVR+ than with IVR ($6 and $16 for IVR and IVR+, respectively). For statins, the incremental cost-effectiveness ratio for each percent adherence increase was about 7 times higher with IVR+ than with IVR ($6 and $43 for IVR and IVR+, respectively). Considering potential cost offsets from reduced cardiovascular events, the probability of breakeven was the highest for UC, but the IVR-based interventions had a higher probability of breakeven for subgroups with a baseline low-density lipoprotein (LDL) level of more than 100 mg/dl and those with two or more calls. Conclusions We found that the use of an automated voice messaging system to promote adherence to ACEIs/ARBs and statins may be cost-effective, depending on a decision maker’s willingness to pay for unit increase in adherence. When considering changes in LDL level and downstream medical care offsets, UC is the optimal strategy for the general population. However, IVR-based interventions may be the optimal choice for those with elevated LDL values at baseline.
Abstract Purpose In 2009, the US Food and Drug Administration (FDA) mandated a label change for leukotriene inhibitors (LTIs) to include neuropsychiatric adverse events (eg, depression and ...suicidality) as a precaution. This study investigated how this label change affected the use of LTIs and other asthma controller medications, mental health visits, and suicide attempts. Methods We analyzed data (2005-2010) from 5 large health plans in the US Population-Based Effectiveness in Asthma and Lung Diseases (PEAL) Network. The study cohort included children and adolescents (n = 30,000), young adults (n = 20,000), and adults (n = 90,000) with asthma. We used interrupted time series to examine changes in rates of LTI dispensings, non-LTI dispensings, mental health visits, and suicide attempts (using a validated algorithm based on a combination of diagnoses of injury or poisoning and psychiatric conditions). Findings The label change was associated with abrupt reductions in LTI use among all age groups (relative reductions of 8.3%, 15.1%, and 6.0% among adolescents, young adults, and adults, respectively, compared with expected rates at 1 year after the warnings). Although we detected immediate offset increases in non-LTI asthma medication use, these increases were not sustained among adolescents and young adults. There were small increases in mental health visits among LTI users. Implications The FDA label change for LTIs communicated possible risk of neuropsychiatric events. Communication and enhanced awareness may have increased reporting of mental health symptoms among young adults and adults. It is important to assess intended and unintended consequences of FDA warnings and label changes.
Background Dietary studies designed to decrease the urinary albumin excretion rate (AER) typically reduce protein by increasing lower protein plant foods and decreasing higher protein animal ...products. Study Design We evaluated AER while increasing protein intake in the Dietary Approaches to Stop Hypertension (DASH) Trial (randomized, parallel group, 8 week controlled feeding). Setting & Participants 378 individuals without diabetes with prehypertension or stage I hypertension. Intervention The DASH diet, 18% energy from protein, emphasizes, among other features, low-fat dairy products; and the fruit/vegetable (FV) and control diets, each with 15% energy from protein. Outcome AER. Measurements We measured AER by using immunoassay and covariates at baseline and after 8 weeks. Results Baseline AER had a geometric mean value of 4.0 ± 0.2 (SE) mg/24 h. In 285 participants with baseline AER less than 7 mg/24 h, AER was unchanged by diet treatment (geometric mean, 2.5 ± 0.2 mg/24 h in the control diet, 3.0 ± 0.2 mg/24 h in the FV diet, and 2.8 ± 0.2 mg/24 h in the DASH diet). Conversely, in 93 participants with baseline AER of 7 mg/24 h or greater, end-of-feeding AER was lower in the FV diet (6.6 ± 1.0 mg/24 h) than in the control (11.4 ± 1.8 mg/24 h; P = 0.01) or DASH diets (11.7 ± 1.6 mg/24 h; P = 0.005). The DASH and control diets were not different ( P = 0.9). Limitations Long-term AER change not studied. Conclusions The decrease in AER after 8 weeks occurred in only those with high-normal baseline AER in the FV diet, in a pattern distinct from the blood pressure decrease. The DASH diet did not increase AER despite a 3% increase in energy from protein.
Based on results of clinical trials, inhaled corticosteroids (ICS) are the most-effective controller medications for preventing asthma-related exacerbations, yet few studies in real-life populations ...have evaluated the comparative effectiveness of ICS.
To determine the likelihood of asthma exacerbations among children with asthma after initiation of controller medications: ICS, leukotriene antagonists (LTRA), and ICS-long-acting β-agonist (LABA) combination therapy.
This was a retrospective cohort study of subjects who were part of the Population-Based Effectiveness in Asthma and Lung Diseases Network. We conducted Cox regression analyses by adjusting for baseline covariates, adherence by using proportion of days covered, and high-dimensional propensity scores. The main outcome measurements were emergency department visits, hospitalizations, or oral corticosteroid use.
Our population included 15,567 health plan subjects and 10,624 TennCare Medicaid subjects with uncontrolled asthma. Overall adherence to controller medications was low, with no more than 50% of the subjects refilling the medication after the initial fill. For subjects with allergic rhinitis, the subjects in TennCare Medicaid treated with LTRAs were less likely to experience ED visits (hazard ratio 0.44 95% CI, 0.21-0.93) compared with the subjects treated with ICS. For all other groups, the subjects treated with LTRA or ICS-LABA were just as likely to experience ED visits or hospitalizations, or need oral corticosteroids as the subjects treated with ICS.
Risks of asthma-related exacerbations did not differ between children who initiated LTRA and ICS. These findings may be explainable by LTRA, which has similar effectiveness as ICS in real-life usage by residual confounding by indication or other unmeasured factors.
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