Performance of the Asthma Impact on Quality of Life Scale (A-IQOLS) in diverse asthma research populations and demographic subgroups.

BACKGROUND: The Asthma Impact on Quality of Life Scale (A-IQOLS) assesses the patient-perceived negative effect of asthma on quality of life. Its standard error of measurement is known; it has strong construct, convergent, and divergent validity; and it provides information that is unique among asthma outcome measures. OBJECTIVE: We sought to characterize the psychometric properties of the A-IQOLS and its suitability for use in demographically and clinically diverse adult asthmatic populations. METHODS: Data from participants in 5 independent asthma studies, with samples ranging from patients with well-controlled moderate asthma to patients with severe poorly controlled asthma, were pooled to determine the psychometric performance of A-IQOLS scores overall and in multiple demographic, disease status, and study subgroups. RESULTS: Pooled sample (n = 597) age averaged 45 years; 66% were female, 65% were white, 22% were African American, 11% were Hispanic, and 11% had a high school education or less. The rated importance of its underlying life dimensions and associations between A-IQOLS scores and lung function, symptom, Asthma Control Test, Juniper Mini Asthma Quality of Life Questionnaire, and Marks Asthma Quality of Life Questionnaire scores was very similar, regardless of patients' demographic and clinical characteristics. A-IQOLS scores discriminated among the individual study samples, as well as other patient-reported symptom and functional status measures. Distribution and anchor-based considerations suggest an A-IQOLS minimum clinically important difference in the vicinity of 0.50 and not less than 0.33 scale score units. CONCLUSIONS: A-IQOLS is valid for research and potentially clinical use in demographically and clinically diverse patients.

A new measure to assess asthma's effect on quality of life from the patient's perspective.

BACKGROUND: The Asthma Impact on Quality of Life Scale (A-IQOLS) assesses the negative effect of asthma on quality of life (QoL) from the patient's perspective by using dimensions of Flanagan's Quality of Life Scale (QOLS), a measure of current QoL. OBJECTIVES: We sought to determine and compare the psychometric properties of the A-IQOLS and QOLS, including their sensitivities to differences and change in asthma status. METHODS: In a test-retest design (3- to 5-week interval) adults with persistent asthma underwent spirometry and were administered the A-IQOLS, other asthma outcome measures (Asthma Control Test, Asthma Symptom Utility Index, and the Marks and Juniper Asthma Quality of Life Questionnaires), and the QOLS. RESULTS: Participants' (n = 147) mean age was 49 years, 76% were white, 12% were Hispanic, and 65% were female. A-IQOLS and QOLS scores were significantly correlated with other asthma outcomes scores, except FEV1, but shared relatively low common variance with these measures. A-IQOLS but not QOLS score changes were significantly correlated with changes in asthma outcomes. An A-IQOLS standard error of measurement of 0.27 implies that a within-person score change of ±0.73 or greater constitutes a true change. The QOLS standard error of measurement was 0.43. CONCLUSIONS: A-IQOLS provides a reliable, valid, and unique assessment of the patient-perceived negative effect of asthma on QoL that is suitable for use in asthma clinical research and potentially in clinical care. Further studies are needed in diverse patient populations. QOLS, a measure of current QoL, is less sensitive to disease status changes but might be useful in characterizing study populations, in treatment adherence research, and as a clinical and research tool in patients with multiple, severe, and/or life-limiting chronic conditions.

Pilot randomised trial of a healthy eating behavioural intervention in uncontrolled asthma.

Rigorous research on the benefit of healthy eating patterns for asthma control is lacking.We randomised 90 adults with objectively confirmed uncontrolled asthma and a low-quality diet (Dietary Approaches to Stop Hypertension (DASH) scores <6 out of 9) to a 6-month DASH behavioural intervention (n=46) or usual-care control (n=44). Intention-to-treat analyses used repeated-measures mixed models.Participants were middle-aged, 67% female and multiethnic. Compared with controls, intervention participants improved on DASH scores (mean change (95% CI) 0.6 (0, 1.1) versus -0.3 (-0.8, 0.2); difference 0.8 (0.2, 1.5)) and the primary outcome, Asthma Control Questionnaire scores (-0.2 (-0.5, 0) versus 0 (-0.3, 0.3); difference -0.2 (-0.5, 0.1)) at 6 months. The mean group differences in changes in Mini Asthma Quality of Life Questionnaire overall and subdomain scores consistently favoured the intervention over the control group: overall 0.4 (95% CI 0, 0.8), symptoms 0.5 (0, 0.9), environment 0.4 (-0.1, 1.0), emotions 0.4 (-0.2, 0.9) and activities 0.3 (0, 0.7). These differences were modest, but potentially clinical significant.The DASH behavioural intervention improved diet quality with promising clinical benefits for better asthma control and functional status among adults with uncontrolled asthma. A full-scale efficacy trial is warranted.

Acceptability and feasibility of the 'DASH for Asthma' intervention in a randomized controlled trial pilot study.

OBJECTIVE: 'DASH for Asthma' (n 90) was a 6-month randomized controlled trial that demonstrated potential benefits of a DASH (Dietary Approaches to Stop Hypertension) behavioural intervention for improving diet quality and asthma control by comparing intervention to usual care in adults with uncontrolled asthma. The present study examined acceptability and feasibility of the intervention from the perspective of intervention participants and lifestyle coaches. DESIGN: Grounded in Social Cognitive Theory, the 3-month intensive stage, including three individual and eight group sessions, focused on diet modifications and behavioural self-regulation. The 3-month maintenance stage contained telephone consultations. Participants and lifestyle coaches completed surveys including 5-point Likert scales and open-ended questions. We analysed data using descriptive and inductive content analyses. SUBJECTS: Forty-six intervention participants (survey response rate was 65-72 %) and two lifestyle coaches. RESULTS: Participants and lifestyle coaches were highly satisfied (all mean ratings >4) with individual and group sessions. Participants identified mastery of knowledge and skills (awareness, goal setting, self-monitoring, problem solving), social learning (class members sharing experiences and ideas) and good coaching skills (reflective listening, empathy, motivational counselling) as important contributors to self-efficacy and programme satisfaction. Participants also valued personalized feedback received in individual sessions. Lifestyle coaches viewed participant engagement as a facilitator to effective sessions. Finally, participants and lifestyle coaches identified food tasting as beneficial for observational learning and facilitation of participant engagement. High class attendance and self-monitoring rate also reflected the high engagement among participants. CONCLUSIONS: The DASH behavioural intervention was feasible and highly acceptable to participants with uncontrolled asthma and lifestyle coaches.

The prevalence of harmful and hazardous alcohol consumption in older U.S. adults: data from the 2005-2008 National Health and Nutrition Examination Survey (NHANES).

BACKGROUND: Alcohol consumption and its interaction with disease, medication use, and functional status may result in serious health problems, but little information exists about the national prevalence of alcohol-related health risk in older adults. OBJECTIVE: To estimate the prevalence of harmful and hazardous alcohol use and the prevalence of consumption in excess of National Institute of Alcohol Abuse and Alcoholism (NIAAA) recommendations, in people aged 65 and older, and by sex and race/ethnicity sub-group. DESIGN: Cross-sectional, using data from the 2005-2008 National Health and Nutrition Examination Survey of the non-institutionalized U.S. population. PARTICIPANTS: One thousand and eighty-three respondents aged 65 and older who consume alcohol. MAIN MEASURES: Participants' alcohol consumption was classified as Harmful, Hazardous, or Healthwise, in the context of their specific health status, using the Alcohol-Related Problems Survey classification algorithm. KEY RESULTS: Overall, 14.5 % of older drinkers (95 % CI: 12.1 %, 16.8 %) consumed alcohol above the NIAAA's recommended limits. However, when health status was taken into account, 37.4 % of older drinkers (95 % CI: 34.9 %, 40.0 %) had Harmful consumption and 53.3 % (95 % CI: 50.1 %, 56.6 %) had either Hazardous or Harmful consumption. Among light/moderate drinkers, the proportions were 17.7 % (95 % CI: 14.7 %, 20.7 %) and 28.0 % (95 % CI: 24.8 %, 31.1 %), respectively. Male drinkers had significantly greater odds of Hazardous/Harmful consumption than female drinkers (OR = 2.14 [95 % CI: 1.77, 2.6]). Black drinkers had worse health status and significantly greater odds of Hazardous/Harmful consumption than white drinkers (OR = 1.49; 95 % CI: 1.02, 2.17), despite having no greater prevalence of drinking in excess of NIAAA-recommended limits. CONCLUSION: Most older Americans who drink are light/moderate drinkers, yet substantial proportions of such drinkers drink in a manner that is either harmful or hazardous to their health. Older adults with risky alcohol consumption are unlikely to be identified by health care providers if clinicians rely solely on whether patient consumption exceeds the NIAAA-recommended limits.

Mediators of asthma outcomes.

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.

Asthma outcomes: quality of life.

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.

Translating an evidence-based lifestyle intervention program into primary care: lessons learned.

The E-LITE (Evaluation of Lifestyle Interventions to Treat Elevated Cardiometabolic Risk in Primary Care) trial evaluated the feasibility and potential effectiveness of translating an evidence-based lifestyle intervention for the management of obesity and related risk factors in a primary care setting. Delivered by allied health care providers, the intervention promoted at least 7% weight loss and at least 150 minutes per week of moderate-intensity physical activity through gradual, sustainable lifestyle changes. Activities included interactive group lessons, food tasting, guided physical activity, and technology-mediated self-monitoring and behavioral counseling. This article discusses insights and potential areas for improvement to strengthen program implementation for dissemination of the E-LITE program to other primary care settings. We focus on (a) the role of allied health professionals in program delivery, (b) strengthening program integration within a primary care clinic, and (c) the use of information technology to extend the reach and impact of the program. Our experience shows the feasibility of implementing an evidence-based lifestyle intervention program combining group-delivered nutrition and behavioral counseling, physical activity training, and technology-mediated follow-up in a primary care setting. Challenges remain, and we offer possible solutions to overcome them.

Asthma in the elderly: Current understanding and future research needs--a report of a National Institute on Aging (NIA) workshop.

Asthma in the elderly is underdiagnosed and undertreated, and there is a paucity of knowledge on the subject. The National Institute on Aging convened this workshop to identify what is known and what gaps in knowledge remain and suggest research directions needed to improve the understanding and care of asthma in the elderly. Asthma presenting at an advanced age often has similar clinical and physiologic consequences as seen with younger patients, but comorbid illnesses and the psychosocial effects of aging might affect the diagnosis, clinical presentation, and care of asthma in this population. At least 2 phenotypes exist among elderly patients with asthma; those with longstanding asthma have more severe airflow limitation and less complete reversibility than those with late-onset asthma. Many challenges exist in the recognition and treatment of asthma in the elderly. Furthermore, the pathophysiologic mechanisms of asthma in the elderly are likely to be different from those seen in young asthmatic patients, and these differences might influence the clinical course and outcomes of asthma in this population.

Association between objective measures and parent-reported measures of child tobacco smoke exposure: A secondary data analysis of four trials.

INTRODUCTION: Tobacco smoke exposure (TSE) harms children and adults. Studies of childhood TSE exposure often relies on parental reports, but may benefit from objective measures. The objective of our study was to study the relationship between reported and objective measures of TSE. METHODS: We analyzed data from four intervention trials, conducted in clinical or community settings, to identify objective measures most closely associated with parent-reported measures and the optimal set of parent-reported measures for predicting objective measures. We also assessed whether there was a learning curve in reported exposure over time, and the importance of replicate biomarker measures. RESULTS: Correlations between objective and parent-reported measures of child TSE were modest at best, ranging from zero to 0.41. Serum cotinine and urinary cotinine were most strongly associated with parental reports. Parental questions most closely related to biomarkers were number of cigarettes and home smoking rules; together these formed the best set of predictive questions. No trial included all objective measures and all questions, precluding definitive statements about relative advantages. Within-subject repeatability of biomarker measures varied across studies, suggesting that direct pilot data are needed to assess the benefit of replicate measurements. CONCLUSIONS: Improvements in objective and parent-reported child exposure measurements are needed to accurately monitor child TSE, evaluate efforts to reduce such exposure, and better protect child health.

Comparison of dynamic block randomization and minimization in randomized trials: a simulation study.

BACKGROUND: Minimizing the imbalance of key baseline covariates between treatments is known to be very important to the precision of the estimate of treatment effect in clinical research. Dynamic randomization allocation techniques have been used to achieve balance across multiple baseline characteristics. However, empirical data are limited on how these techniques compare in terms of balance and efficiency. We are motivated by a newly funded randomized controlled trial, in which we have the option of choosing between two methods of randomization at the subject level: (1) randomizing individual subjects consecutively as they are enrolled, using Pocock and Simon's minimization method, and (2) simultaneously randomizing blocks of subjects once all subjects in a block have been enrolled, using a balance algorithm originally developed for cluster randomized trials. PURPOSE: To compare dynamic block randomization and minimization in terms of balance on baseline covariates and statistical efficiency. Simple randomization was included as a reference. METHODS: A simulation study using data from a previous randomized controlled trial was conducted to compare balance statistics and the accuracy and power of hypothesis testing among the randomization methods. RESULTS: Dynamic block randomization consistently produced the best balance and highest power for various sample and treatment effect sizes, even after post-adjustment of the pre-specified baseline covariates in all three methods. Consistent with previous reports, minimization performed better in balance and power than simple randomization; however, the differences were noticeably smaller compared to those between dynamic block randomization and simple randomization. LIMITATIONS: In this simulation study, we considered three sample sizes and two block sizes for a two-arm randomized trial. We assumed no interactions among the multiple baseline covariates. It is necessary to evaluate how the results may vary when the simulation conditions are changed before drawing broader conclusions regarding comparisons between the randomization methods. CONCLUSIONS: This study demonstrates that dynamic block randomization outperforms minimization with regard to achieving balance and maximizing efficiency. Nevertheless, the differences across the three randomization strategies are modest. The statistical advantages associated with dynamic block randomization need to be considered in relation to the planned sample size and the practical issues for its implementation in deciding the preferred method of randomization for a given trial (e.g., the time required to accrue blocks of subjects of adequate size as balanced against the need to commence intervention/treatment immediately in those randomized to that experimental condition).

Shared treatment decision making improves adherence and outcomes in poorly controlled asthma.

RATIONALE: Poor adherence to asthma controller medications results in poor treatment outcomes. OBJECTIVES: To compare controller medication adherence and clinical outcomes in 612 adults with poorly controlled asthma randomized to one of two different treatment decision-making models or to usual care. METHODS: In shared decision making (SDM), nonphysician clinicians and patients negotiated a treatment regimen that accommodated patient goals and preferences. In clinician decision making, treatment was prescribed without specifically eliciting patient goals/preferences. The otherwise identical intervention protocols both provided asthma education and involved two in-person and three brief phone encounters. MEASUREMENTS AND MAIN RESULTS: Refill adherence was measured using continuous medication acquisition (CMA) indices-the total days' supply acquired per year divided by 365 days. Cumulative controller medication dose was measured in beclomethasone canister equivalents. In follow-up Year 1, compared with usual care, SDM resulted in: significantly better controller adherence (CMA, 0.67 vs. 0.46; P < 0.0001) and long-acting beta-agonist adherence (CMA, 0.51 vs. 0.40; P = 0.0225); higher cumulative controller medication dose (canister equivalent, 10.9 vs. 5.2; P < 0.0001); significantly better clinical outcomes (asthma-related quality of life, health care use, rescue medication use, asthma control, and lung function). In Year 2, compared with usual care, SDM resulted in significantly lower rescue medication use, the sole clinical outcome available for that year. Compared with clinician decision making, SDM resulted in: significantly better controller adherence (CMA, 0.67 vs. 0.59; P = 0.03) and long-acting beta-agonist adherence (CMA, 0.51 vs. 0.41; P = 0.0143); higher cumulative controller dose (CMA, 10.9 vs. 9.1; P = 0.005); and quantitatively, but not significantly, better outcomes on all clinical measures. CONCLUSIONS: Negotiating patients' treatment decisions significantly improves adherence to asthma pharmacotherapy and clinical outcomes. Clinical trials registered with www.clinicaltrials.gov (NCT00217945 and NCT00149526).

Development of the ATAQ-IPF: a tool to assess quality of life in IPF.

BACKGROUND: There is no disease-specific instrument to assess health-related quality of life (HRQL) in patients with idiopathic pulmonary fibrosis (IPF). METHODS: Patients' perspectives were collected to develop domains and items for an IPF-specific HRQL instrument. We used item variance and Rasch analysis to construct the ATAQ-IPF (A Tool to Assess Quality of life in IPF). RESULTS: The ATAQ-IPF version 1 is composed of 74 items comprising 13 domains. All items fit the Rasch model. Domains and the total instrument possess acceptable psychometric characteristics for a multidimensional questionnaire. The pattern of correlations between ATAQ-IPF scores and physiologic variables known to be important in IPF, along with significant differences in ATAQ-IPF scores between subjects using versus those not using supplemental oxygen, support its validity. CONCLUSIONS: Patient-centered and careful statistical methodologies were used to construct the ATAQ-IPF version 1, an IPF-specific HRQL instrument. Simple summation scoring is used to derive individual domain scores as well as a total score. Results support the validity of the ATAQ-IPF, and future studies will build on that validity.

The Breathe Easier through Weight Loss Lifestyle (BE WELL) Intervention: a randomized controlled trial.

BACKGROUND: Obesity and asthma have reached epidemic proportions in the US. Their concurrent rise over the last 30 years suggests that they may be connected. Numerous observational studies support a temporally-correct, dose-response relationship between body mass index (BMI) and incident asthma. Weight loss, either induced by surgery or caloric restriction, has been reported to improve asthma symptoms and lung function. Due to methodological shortcomings of previous studies, however, well-controlled trials are needed to investigate the efficacy of weight loss strategies to improve asthma control in obese individuals. METHODS/DESIGN: BE WELL is a 2-arm parallel randomized clinical trial (RCT) of the efficacy of an evidence-based, comprehensive, behavioral weight loss intervention, focusing on diet, physical activity, and behavioral therapy, as adjunct therapy to usual care in the management of asthma in obese adults. Trial participants (n = 324) are patients aged 18 to 70 years who have suboptimally controlled, persistent asthma, BMI between 30.0 and 44.9 kg/m2, and who do not have serious comorbidities (e.g., diabetes, heart disease, stroke). The 12-month weight loss intervention to be studied is based on the principles of the highly successful Diabetes Prevention Program lifestyle intervention. Intervention participants will attend 13 weekly group sessions over a four-month period, followed by two monthly individual sessions, and will then receive individualized counseling primarily by phone, at least bi-monthly, for the remainder of the intervention. Follow-up assessment will occur at six and 12 months. The primary outcome variable is the overall score on the Juniper Asthma Control Questionnaire measured at 12 months. Secondary outcomes include lung function, asthma-specific and general quality of life, asthma medication use, asthma-related and total health care utilization. Potential mediators (e.g., weight loss and change in physical activity level and nutrient intake) and moderators (e.g., socio-demographic characteristics and comorbidities) of the intervention effects also will be examined. DISCUSSION: This RCT holds considerable potential for illuminating the nature of the obesity-asthma relationship and advancing current guidelines for treating obese adults with asthma, which may lead to reduced morbidity and mortality related to the comorbidity of the two disorders. TRIAL REGISTRATION: NCT00901095.

The effect of an inhaled corticosteroid on glucose control in type 2 diabetes.

OBJECTIVE: To determine the effect of inhaled corticosteroid (ICS) therapy on glucose control in adults with type 2 diabetes mellitus and coexisting asthma or chronic obstructive pulmonary disease (COPD). DESIGN: A prospective randomized, double-blind, double-dummy placebo-controlled, crossover investigation of inhaled steroids and oral leukotriene blockers. SETTING: A United States Department of Veterans Affairs Health Care System outpatient setting. PARTICIPANTS: Adults with type 2 diabetes and asthma or COPD. METHODS: Subjects (n=12) were randomized to receive either inhaled fluticasone propionate (440 microg twice daily) and oral placebo, or inhaled placebo and oral montelukast (10 mg/day). After 6 weeks, subjects were switched to the opposite therapy for 6 weeks. The primary outcome measure was the change in the percentage of glycosylated hemoglobin (%HbA1c) at 6 weeks relative to the baseline value. RESULTS: Ten patients completed the study. The difference between the mean within-subject changes in %HbA1c associated with 6-week periods of fluticasone and the mean changes associated with montelukast therapy was small but statistically significant (mean difference=0.25; P<0.025). Neither fluticasone nor oral montelukast therapy for 6 weeks led to a significantly different mean % HbA1c compared with the relevant baseline (mean differences=0.11 and -0.14, respectively). CONCLUSION: The absence of a clinically significant within-subject difference in the changes in %HbA1c associated with fluticasone versus oral montelukast therapy, or between either therapy or baseline does not warrant recommending changes in therapy for asthma or diabetes in patients with these co-morbid conditions. However, we suggest that clinicians carefully monitor blood glucose control when diabetic patients initiate ICS, especially with higher dosages.

Evaluation of lifestyle interventions to treat elevated cardiometabolic risk in primary care (E-LITE): a randomized controlled trial.

BACKGROUND: Efficacy research has shown that intensive individual lifestyle intervention lowers the risk for developing type 2 diabetes mellitus and the metabolic syndrome. Translational research is needed to test real-world models of lifestyle interventions in primary care settings. DESIGN: E-LITE is a three-arm randomized controlled clinical trial aimed at testing the feasibility and potential effectiveness of two lifestyle interventions: information technology-assisted self-management, either alone or in combination with care management by a dietitian and exercise counselor, in comparison to usual care. Overweight or obese adults with pre-diabetes and/or metabolic syndrome (n = 240) recruited from a community-based primary care clinic are randomly assigned to one of three treatment conditions. Treatment will last 15 months and involves a three-month intensive treatment phase followed by a 12-month maintenance phase. Follow-up assessment occurs at three, six, and 15 months. The primary outcome is change in body mass index. The target sample size will provide 80% power for detecting a net difference of half a standard deviation in body mass index at 15 months between either of the self-management or care management interventions and usual care at a two-sided alpha level of 0.05, assuming up to a 20% rate of loss to 15-month follow-up. Secondary outcomes include glycemic control, additional cardiovascular risk factors, and health-related quality of life. Potential mediators (e.g., treatment adherence, caloric intake, physical activity level) and moderators (e.g., age, gender, race/ethnicity, baseline mental status) of the intervention's effect on weight change also will be examined. DISCUSSION: This study will provide objective evidence on the extent of reductions in body mass index and related cardiometabolic risk factors from two lifestyle intervention programs of varying intensity that could be implemented as part of routine health care.

Secondhand tobacco smoke in children with asthma: sources of and parental perceptions about exposure in children and parental readiness to change.

BACKGROUND: Secondhand smoke triggers childhood asthma. Understanding sources of exposure, parental beliefs about exposure, and readiness to change that exposure are important for designing smoke exposure reduction interventions. METHODS: As part of screening for a clinical trial of a smoke exposure reduction intervention, 519 smoke-exposed children 3 to 12 years old with asthma provided urine specimens for cotinine testing, and their primary caregivers completed questionnaires. RESULTS: The urine cotinine to creatinine ratio (CCR) was lowest if neither the primary caregiver nor day-care provider smoked (mean CCR, 14.0; SD, 14.4), greater if either smoked (mean CCR, 22.2; SD, 21.3; and mean, CCR, 26.3; SD, 22.2, respectively), and greatest if both smoked (mean CCR, 39.6; SD, 27.5; p < 0.01). Parental perception of their child's exposure was weakly associated with the child's CCR (r(2) = 0.11, p < 0.001). Most parents (58.3%) reported that tobacco smoke exposure had small/no negative effect on their child's asthma. Substantial proportions of those for whom a specific exposure reduction action was relevant were classified as contemplating, preparing, or had recently taken action to reduce their child's exposure, including smoking cessation (61.3%), keeping the child out of smoke-exposed places (72.7%), and making the child's home (49.2%) and areas out of the home smoke free (66.9%). CONCLUSIONS: Smoking by the primary caregiver and day-care provider are important sources of exposure for children with asthma. Parental assessment of their child's exposure is associated with biologically confirmed exposure but cannot be relied on to assess that exposure. Although the harm of smoke exposure was frequently underestimated, many parents appeared receptive to considering action to reduce their child's exposure. TRIAL REGISTRATION: (Clinicaltrials.gov). Identifier: NCT00217958.

Adding an alcohol-related risk score to an existing categorical risk classification for older adults: sensitivity to group differences.

OBJECTIVES: To evaluate a new alcohol-related risk score for research use. DESIGN: Using data from a previously reported trial of a screening and education system for older adults (Computerized Alcohol-Related Problems Survey), secondary analyses were conducted comparing the ability of two different measures of risk to detect post-intervention group differences: the original categorical outcome measure and a new, finely grained quantitative risk score based on the same research-based risk factors. SETTING: Three primary care group practices in southern California. PARTICIPANTS: Six hundred sixty-five patients aged 65 and older. MEASUREMENTS: A previously calculated, three-level categorical classification of alcohol-related risk and a newly developed quantitative risk score. RESULTS: Mean post-intervention risk scores differed between the three experimental conditions: usual care, patient report, and combined report (P<.001). The difference between the combined report and usual care was significant (P<.001) and directly proportional to baseline risk. The three-level risk classification did not reveal approximately 57.3% of the intervention effect detected by the risk score. The risk score also was sufficiently sensitive to detect the intervention effect within the subset of hypertensive patients (n=112; P=.001). CONCLUSION: As an outcome measure in intervention trials, the finely grained risk score is more sensitive than the trinary risk classification. The additional clinical value of the risk score relative to the categorical measure needs to be determined.