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Biomedical subjects

Robert A Wise

Publications and source records attributed to Robert A Wise.

At least 19 recordsLinked to original sources
PubMed2006

The creation of emergency health care standards for catastrophic events.

The creation of health care standards by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) in a defined area with known events follows a predictable process. A problem area (e.g., hand hygiene) is identified from multiple sources. The JCAHO then calls together experts from around the country, and through debate and the comparison of positions of various people within the health care arena, a new standard informed by these views can be developed. Once developed, it is vetted and becomes established as a Joint Commission standard. But what happens when an event has never happened, cannot be reliably predicted, and, one hopes, will never come to pass? How can one create any meaningful standards? This is the situation when considering a number of scenarios related to disasters and mass casualty events.

Delivery of Health Care↗
PubMed2006

Variability of spirometry in chronic obstructive pulmonary disease: results from two clinical trials.

OBJECTIVE: Our goal is to determine short-term intraindividual biologic and measurement variability in spirometry of patients with a wide range of stable chronic obstructive pulmonary disease severity, using datasets from the National Emphysema Treatment Trial (NETT) and the Lung Health Study (LHS). This may be applied to determine criteria that can be used to assess a clinically meaningful change in spirometry. METHODS: A total of 5,886 participants from the LHS and 1,215 participants from the NETT performed prebronchodilator spirometry during two baseline sessions. We analyzed varying criteria for absolute and percent change of FEV(1) and FVC to determine which criterion was met by 90% of the participants. RESULTS: The mean +/- SD FEV(1) for the initial session was 2.64 +/- 0.60 L (75.1 +/- 8.8% predicted) for the LHS and 0.68 +/- 0.22 L (23.7 +/- 6.5% predicted) for the NETT. The mean +/- SD number of days between test sessions was 24.9 +/- 17.1 for the LHS and 85.7 +/- 21.7 for the NETT. As the degree of obstruction increased, the intersession percent difference of FEV(1) increased. However, the absolute difference between tests remained relatively constant despite the severity of obstruction (0.106 +/- 0.10 L). Over 90% of participants had an intersession FEV(1) difference of less than 225 ml irrespective of the severity of obstruction. CONCLUSIONS: Absolute changes in FEV(1) rather than percent change should be used to determine whether patients with chronic obstructive pulmonary disease have improved or worsened between test sessions.

Aged↗
PubMed2006

The value of forced expiratory volume in 1 second decline in the assessment of chronic obstructive pulmonary disease progression.

Forced expiratory volume in 1 second (FEV1) declines normally with aging by approximately 30 mL/yr, but in susceptible smokers, the decline is greater (about 60 mL/yr), resulting in the development of chronic obstructive pulmonary disease (COPD). Smoking cessation usually restores the normal or near-normal rate of FEV1 decline, whereas intermittent quitting provides less benefit. Thus, smoking cessation is a critical component for the prevention of COPD progression. FEV1 is central to the definition of COPD and classification of its severity. FEV1 is a good predictor of exercise tolerance and correlates with survival and quality of life. More rapid FEV1 decline is also predictive of morbidity, mortality, and hospitalization rates. Risk factors for accelerated decline in FEV1, in addition to smoking, include frequent exacerbations, airways reactivity, and possibly chronic systemic inflammation. Genetic components of the decline in FEV1 are being actively explored, but none has been extensively validated other than alpha1-antitrypsin deficiency. To date, only smoking cessation has been definitively shown to be effective in reducing the rate of FEV1 decline, but other therapeutic strategies are under active research. Consequently, FEV1 and its change over time are important outcomes in COPD and valuable measures for the assessment of disease progression.

Disease Progression↗
PubMed2006

Respiratory physiologic changes in pregnancy.

In summary, the major physiologic changes that occur in pregnancy are the increased minute ventilation, which is caused by increased respiratory center sensitivity and drive; a compensated respiratory alkalosis; and a low expiratory reserve volume. The vital capacity and measures of forced expiration are well preserved. Patients who have many lung diseases tolerate pregnancy well, with the exception of those who have pulmonary hypertension or chronic respiratory insufficiency from parenchymal or neuromuscular disease.

Female↗
PubMed2006

Effect of obesity on clinical presentation and response to treatment in asthma.

Obesity is a risk factor for being diagnosed with asthma, but there is conflicting evidence on whether obesity is a risk factor for lung function abnormalities characteristic of asthma. We studied a cohort of 488 subjects, 47% of whom were obese. Obese and non-obese subjects with asthma had similar airflow limitation and bronchodilator responsiveness, but obese participants had increased sleep disturbance and gastroesophageal reflux disease, higher cytokine levels, and a trend towards increased exacerbations when treated with theophylline. Obese and non-obese asthmatics have similar lung function abnormalities, but comorbidities and altered responses to medications may significantly affect asthma control in obese people.

Acetates↗
PubMed2006

Allergic rhinitis and sinusitis in asthma: differential effects on symptoms and pulmonary function.

BACKGROUND: Allergic rhinitis and sinusitis are frequently associated with asthma. The purpose of this study was to determine the impact of self-reported allergic rhinitis and sinusitis on lower airway disease in a large cohort of participants with well-characterized asthma. METHODS: A cohort study of participants in two trials of the American Lung Association-Asthma Clinical Research Centers: 2,031 asthmatics in the Safety of Inactivated Influenza Vaccine in Asthma in Adults and Children (SIIVA) trial and 488 asthmatics in the Effectiveness of Low Dose Theophylline as Add-on Treatment in Asthma (LODO) trial. At baseline, participants reported the presence of allergic rhinitis and sinusitis, and then lung function and asthma control were measured. During the trials, participants were monitored for asthma exacerbations. RESULTS: More than 70% of participants reported either allergic rhinitis or sinusitis. Sinusitis was more common in female patients (odds ratio, 1.46 [SIIVA]), those with gastroesophageal reflux disease (odds ratio, 2.21 [SIIVA]), and those of white race (odds ratio, 1.53 [SIIVA]). Similar associations were seen for allergic rhinitis. LODO participants with allergic rhinitis and sinusitis had increased asthma symptoms and a trend toward more sleep disturbance. Participants with allergic rhinitis had higher baseline lung function than those without allergic rhinitis measured by peak flow (91.2% vs 95.8% in the SIIVA trial). Participants with sinusitis had similar lung function to those without sinusitis. Participants with and without allergic rhinitis had similar exacerbation rates. In the LODO trial only, participants with sinusitis had increased asthma exacerbations (5.68 per patient per year vs 3.72 per patient per year). CONCLUSION: Allergic rhinitis and sinusitis are associated with more severe asthmatic symptoms and, in patients with poorly controlled asthma, more exacerbations but are not associated with low lung function.

Adolescent↗
PubMed2006

Feasibility of retinoids for the treatment of emphysema study.

BACKGROUND: Retinoids promote alveolar septation in the developing lung and stimulate alveolar repair in some animal models of emphysema. METHODS: One hundred forty-eight subjects with moderate-to-severe COPD and a primary component of emphysema, defined by diffusing capacity of the lung for carbon monoxide (Dlco) [37.1 +/- 12.0% of predicted] and CT density mask (38.5 +/- 12.8% of voxels <- 910 Hounsfield units) [mean +/- SD] were enrolled into a randomized, double-blind, feasibility study at five university hospitals. Participants received all-trans retinoic acid (ATRA) at either a low dose (LD) [1 mg/kg/d] or high dose (HD) [2 mg/kg/d], 13-cis retinoic acid (13-cRA) [1 mg/kg/d], or placebo for 6 months followed by a 3-month crossover period. RESULTS: No treatment was associated with an overall improvement in pulmonary function, CT density mask score, or health-related quality of life (QOL) at the end of 6 months. However, time-dependent changes in Dlco (initial decrease with delayed recovery) and St. George Respiratory Questionnaire (delayed improvement) were observed in the HD-ATRA cohort and correlated with plasma drug levels. In addition, 5 of 25 participants in the HD-ATRA group had delayed improvements in their CT scores that also related to ATRA levels. Retinoid-related side effects were common but generally mild. CONCLUSIONS: No definitive clinical benefits related to the administration of retinoids were observed in this feasibility study. However, time- and dose-dependent changes in Dlco, CT density mask score, and health-related QOL were observed in subjects treated with ATRA, suggesting the possibility of exposure-related biological activity that warrants further investigation.

Aged↗
PubMed2006

Natural history of mild-moderate pulmonary hypertension and the risk factors for severe pulmonary hypertension in scleroderma.

OBJECTIVE: To determine risk factors for developing pulmonary hypertension (PH) in patients with scleroderma (SSc, systemic sclerosis). METHODS: We used a cohort of 1136 SSc patients using severe PH as the primary outcome in a natural history study. RESULTS: Among 361 individuals with no initial echocardiographic PH, 92 (26.0%) developed mild-moderate PH and 48 (13.6%) severe PH. Patients developing severe PH had lower initial DLCO (48.8% of predicted) than those who did not develop PH (56.8% of predicted). Patients with mild-moderate PH had a 17% probability of progressing to severe PH, and 15.6% probability of regressing to no PH. Individuals with limited disease, mild-moderate PH, and age > or= 47 years at diagnosis had a 27.3% probability of developing severe PH, compared to 8.5% in individuals with diffuse disease, no evidence of PH, and age < 47 years at diagnosis. Longitudinal regression models estimated that individuals with limited disease, mild-moderate PH, and DLCO < 50% predicted had an age-adjusted odds ratio of 8.6 of developing severe PH within 2 years compared to individuals without these risk factors. CONCLUSION: Development of severe PH is uncommon in certain subgroups of SSc patients. Risk factors for progression of PH include older age, limited skin disease, and elevated pulmonary artery pressures at the time of initial evaluation.

Adult↗
PubMed2005

Irreversible lung function deficits in young adults with a history of childhood asthma.

BACKGROUND: Asthma, traditionally characterized as reversible airway obstruction, might lead to structural changes and permanent impairment. OBJECTIVE: We sought to study the frequency, severity, and reversibility of pulmonary deficits in adults with a history of moderate-to-severe childhood allergic asthma. METHODS: Subjects (n = 121) previously enrolled in a randomized trial of immunotherapy for childhood asthma were recalled. Eighty-four young adults (age, 17-30 years; 78% male) were reevaluated by means of spirometry. Subjects with a postbronchodilator FEV1, forced vital capacity, or FEV1/forced vital capacity ratio less than or equal to the 5th percentile or 2 or more indices less than or equal to the 10th percentile (National Health and Nutrition Examination Survey III normative data) were invited to undergo complete pulmonary function testing, physical examination, and chest radiography after 1 week of 1 mg/kg daily prednisone. RESULTS: Of 84 subjects reevaluated, 40 (48%) had one or more spirometric indices less than or equal to the 5th and 10th percentiles (P < .0001). Twenty-eight of the 40 subjects were reassessed after prednisone treatment, of whom 21 (75%) did not improve. Adult and childhood (age 5-12 years) spirometric results were positively correlated (r = 0.49-0.72, P < .001). Abnormal adult spirometric results were associated with a longer duration of asthma at enrollment in the original trial (4.6 vs 6 years, P=.02), increased childhood methacholine sensitivity (PC20, 0.11 vs 0.18 mg/mL; P = .01), and birth prematurity (adjusted odds ratio, 10.7; 95% CI, 1.4-84.5). Immunotherapy status was unrelated to adult lung function. CONCLUSIONS: Many adults with a history of moderate-to-severe allergic asthma in childhood have irreversible lung function deficits. Childhood spirometry, duration of asthma, methacholine sensitivity, and birth prematurity might identify such individuals at a young age.

Adolescent↗
PubMed2005

The effects of a smoking cessation intervention on 14.5-year mortality: a randomized clinical trial.

BACKGROUND: Randomized clinical trials have not yet demonstrated the mortality benefit of smoking cessation. OBJECTIVE: To assess the long-term effect on mortality of a randomly applied smoking cessation program. DESIGN: The Lung Health Study was a randomized clinical trial of smoking cessation. Special intervention participants received the smoking intervention program and were compared with usual care participants. Vital status was followed up to 14.5 years. SETTING: 10 clinical centers in the United States and Canada. PATIENTS: 5887 middle-aged volunteers with asymptomatic airway obstruction. MEASUREMENTS: All-cause mortality and mortality due to cardiovascular disease, lung cancer, and other respiratory disease. INTERVENTION: The intervention was a 10-week smoking cessation program that included a strong physician message and 12 group sessions using behavior modification and nicotine gum, plus either ipratropium or a placebo inhaler. RESULTS: At 5 years, 21.7% of special intervention participants had stopped smoking since study entry compared with 5.4% of usual care participants. After up to 14.5 years of follow-up, 731 patients died: 33% of lung cancer, 22% of cardiovascular disease, 7.8% of respiratory disease other than cancer, and 2.3% of unknown causes. All-cause mortality was significantly lower in the special intervention group than in the usual care group (8.83 per 1000 person-years vs. 10.38 per 1000 person-years; P = 0.03). The hazard ratio for mortality in the usual care group compared with the special intervention group was 1.18 (95% CI, 1.02 to 1.37). Differences in death rates for both lung cancer and cardiovascular disease were greater when death rates were analyzed by smoking habit. LIMITATIONS: Results apply only to individuals with airway obstruction. CONCLUSION: Smoking cessation intervention programs can have a substantial effect on subsequent mortality, even when successful in a minority of participants.

Behavior Therapy↗
PubMed2005

Physician and patient perceptions in COPD: the COPD Resource Network Needs Assessment Survey.

PURPOSE: Chronic obstructive pulmonary disease (COPD), the fourth leading cause of death in the United States, has received disproportionately little attention from physicians and institutions. National data are lacking on patient and physician perceptions of and patterns of care for COPD. METHODS: Linked surveys were administered to national samples of patients with COPD, primary care physicians, and pulmonologists to evaluate perceptions of COPD severity and quality of life, attitudes about COPD, health insurance barriers to COPD care, sources of information, and knowledge about COPD diagnosis and treatment. RESULTS: Overall, 1023 patients with COPD and 1051 primary care physicians and pulmonologists responded to the surveys. Despite experiencing significant symptoms and high health care use, the majority of patients were satisfied with their care. Eighty-eight percent of physicians agreed with the statement that COPD is a "self-inflicted" disease, and more than one third were nihilistic about the treatment of patients who continued to smoke. Patients and physicians reported that insurance problems impeded access to therapies. Patients were generally uninformed about COPD; 54% of primary care physicians were aware of any COPD guidelines. Both patient and physician surveys demonstrated continued confusion about the diagnosis of COPD and treatment choices. There was frequent use of regular oral steroids despite demonstrated lack of efficacy and under-use of pulmonary rehabilitation despite proven efficacy. CONCLUSIONS: Patients with COPD have a high prevalence of activity limitations. Although most physicians believed that proper treatment can slow progression, inadequate knowledge and poor adherence to practice guidelines, together with insurance impediments, negatively impact COPD care.

Adult↗
PubMed2005

Adult asthma severity in individuals with a history of childhood asthma.

BACKGROUND: Childhood asthma can have a range of outcomes in adulthood. OBJECTIVE: To identify clinical features and exposures associated with persistence and severity of childhood asthma in adulthood. METHODS: Eighty-five of 121 subjects previously enrolled in a study of immunotherapy for childhood allergic asthma (age 5-12 years) were re-evaluated with allergy skin testing, spirometry, and interviews about asthma symptoms and medications. These young adults (age 17-30 years; 74% male) all had moderate to severe childhood asthma. Adult asthma severity was scored by using a modified version of National Heart, Lung, and Blood Institute severity categories. RESULTS: Thirteen (15.3%) of 85 adult subjects were in remission despite persistent childhood asthma. Another 19 subjects (22.4%) had only intermittent asthma. The remaining 53 had persistent asthma, of whom 12 (14.1%) had mild asthma, 25 (29.4%) had moderate asthma, and 16 (18.8%) had severe asthma. Subjects in remission, compared with subjects with intermittent or persistent asthma, had lower total serum IgE in childhood (412 ng/mL vs 1136 ng/mL vs 968 ng/mL; P = .02) and fewer positive allergy skin tests (7 vs 9 vs 10 from panel of 18; P = .02). Subjects in remission also had milder childhood asthma, indicated by lower average daily medication usage scores (1.6 vs 3.5 vs 4.4; P = .005) and lower percentage of days on inhaled corticosteroids (13.7% vs 24.7% vs 40.9%; P = .008). No significant association was found between current asthma severity and childhood immunotherapy ( P = .46). CONCLUSION: The prognosis of childhood allergic asthma in adulthood is largely determined early in life. The degree of atopy appears to be a critical determinant of asthma persistence.

Administration, Inhalation↗
PubMed2005

Minimal clinically important differences in the six-minute walk test and the incremental shuttle walking test.

Simple walking tests are widely used for the assessment of functional status in patients with cardiorespiratory disorders. These tests require far less instrumentation than formal cardiopulmonary exercise tests, but they do require standardization of procedures to achieve reproducible results. The most widely used tests for patients with COPD are the 6-minute walking test (6MWT) and the incremental shuttle walking test (SWT). The 6MWT has been characterized in COPD patients with respect to reproducibility and responsivity to change in health status. The 6MWT results are correlated with pulmonary function, health-related quality of life, maximum exercise capacity, and mortality. The minimal clinically important difference (MCID) for the 6MWT is conservatively estimated to be 54-80 meters using both distributional and discriminative methods. For an individual patient, the 6MWT would need to change by about 86 meters to be statistically confident that there has been a change. The SWT has been less extensively validated than the 6MWT, but has similar reproducibility in COPD (CV = approximately 20%). The SWT results improve with pulmonary rehabilitation and bronchodilation, and are highly correlated with maximum oxygen consumption. There are no studies that address the issue of MCID for the SWT. In addition to the MCID, the design and interpretation of COPD clinical trials should take into account the severity of initial impairment, the asymmetry between positive and negative changes, the proportion of patients who show substantial improvement, and the costs and risks of the treatment.

Data Interpretation, Statistical↗
PubMed2004

Racial difference in lung function in African-American and White children: effect of anthropometric, socioeconomic, nutritional, and environmental factors.

African-American children have lower lung volumes than White children. However, the contributions of anthropometric, socioeconomic, nutritional, and environmental factors to this difference are unknown. From participants in the Third National Health and Nutrition Examination Survey (1988-1994), the authors selected 1,462 healthy nonsmoking children (623 White and 839 African-American) aged 8-17 years. The African-American children were taller and heavier but had lower lung function. African Americans were poorer and had lower levels of the antioxidant vitamins A and C and alpha-carotene. The authors performed regression analyses using data on anthropometric, socioeconomic, and nutritional factors and smoke exposure. Adjustment for sitting height explained 42-53% of the racial difference. Socioeconomic factors and antioxidant vitamin levels accounted for an additional 7-10%. Overall, the authors could account for only 50-63% of the racial difference. Exposure to tobacco in the home was weakly associated with forced expiratory volume in 1 second in girls, accounting for 1% of the difference. In children aged 8-12 years (n = 752), birth weight explained 3-5% of the racial difference, whereas in-utero exposure to maternal smoking had no significant effect. The authors conclude that in healthy children, the major explanatory variable for the racial difference in lung function is body habitus; socioeconomic, nutritional, and environmental confounders play a smaller role.

Adolescent↗
PubMed2004

Loss of bone density with inhaled triamcinolone in Lung Health Study II.

Inhaled glucocorticosteroids (ICS) are commonly prescribed for chronic obstructive pulmonary disease. No adverse effect on bone mineral density (BMD) has been proven. In a randomized double-blind, placebo-controlled trial at seven centers in North America, we recruited 412 current smokers or recent quitters with mild to moderate chronic obstructive pulmonary disease. They used inhaled triamcinolone acetonide, 600 mcg, or placebo, twice daily. We measured femoral neck and lumbar spine BMD at baseline and after 1 and 3 years, and serum osteocalcin at baseline, 3 months, 1 year, and 3 years. After 3 years, BMD at the femoral neck decreased 1.78% more with ICS than with placebo (p < 0.001). More participants in the ICS group experienced 6% or more loss of femoral neck BMD (p = 0.002). Lumbar spine BMD increased in the placebo group by 0.98% but decreased by 0.35% in the ICS group (a difference of 1.33%, p = 0.007). Changes in osteocalcin did not correlate with changes in BMD. Fractures, lost height, or osteoporosis diagnoses were not increased among ICS users compared with placebo users. In summary, the use of inhaled triamcinolone acetonide was associated with loss of BMD at the femoral neck and lumbar spine after 3 years of treatment.

Administration, Inhalation↗
PubMed2004

Serum vitamin levels and the risk of asthma in children.

Dietary intake, especially of antioxidant vitamins A, C, E, and the carotenoids, has been linked with the presence and severity of asthma. From the Third National Health and Nutrition Examination Survey (NHANES III), conducted in the United States between 1988 and 1994, the authors selected 4,093 children (aged 6-17 years) for whom relevant medical, socioeconomic, and anthropometric data were complete. The children were 50.6% female, and 9.7% reported a diagnosis of asthma. Bivariate analyses showed that asthma diagnosis was associated with lower levels of serum vitamin C, alpha-carotene, beta-carotene, and beta-cryptoxanthin. However, antioxidant levels may be surrogate markers for socioeconomic variables such as race, poverty, tobacco exposure, or general nutritional status. In logistic models that included age, body mass index, socioeconomic variables, antioxidant levels, parental asthma, and household smoking, the only antioxidants significantly associated with asthma were vitamin C (odds ratio = 0.72 per mg/dl, 95% confidence interval = 0.55, 0.95) and alpha-carotene (odds ratio = 0.95 per micro g/dl, 95% confidence interval = 0.90, 0.99). The odds ratio for asthma in the highest quintile of serum vitamin C relative to the lowest was 0.65 (p < 0.05), whereas it was 0.74 for alpha-carotene (p = 0.066). The authors concluded that low vitamin C and alpha-carotene intakes are associated with asthma risk in children.

Adolescent↗
PubMed2004

Efficacy and tolerability of a selective alpha(2C)-adrenergic receptor blocker in recovery from cold-induced vasospasm in scleroderma patients: a single-center, double-blind, placebo-controlled, randomized crossover study.

OBJECTIVE: OPC-28326 is a selective alpha-adrenergic antagonist with preferential binding to the alpha(2C)-adrenergic receptor (alpha(2C)-AR) subtype. This study observed the effect of OPC-28326 on skin temperature and digital blood flow following an acute cold challenge in patients with Raynaud's phenomenon secondary to scleroderma. METHODS: The study was designed as a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of OPC-28326 (oral doses of 10 mg or 40 mg) or placebo. The primary outcome measures were the time to recover 50% and 70% of the fall (induced by cold challenge) in baseline digital skin temperature. RESULTS: Twelve of 13 enrolled patients completed the study. The mean time to achieve 50% and 70% recovery of the change in prechallenge digital skin temperature was shorter after the OPC-28326 40-mg dose than after placebo (50% recovery at 5.8 minutes versus 10.0 minutes [P = 0.02]; 70% recovery at 13.8 minutes versus 19.5 minutes [P = 0.01]). These recovery times tended to be shorter in the 10 mg OPC-28326 group as well, but the difference versus placebo was not significant (50% recovery at 9.0 minutes versus 10.0 minutes [P = 0.65]; 70% recovery at 15.3 minutes versus 19.5 minutes [P = 0.07]). Total digital blood flow tended to be lower prior to the cold challenge and after administration of 40 mg OPC-28326, as compared with that after placebo, but the difference was not significant. Symptoms that were potentially drug-related were reported more frequently with 40 mg OPC-28326 than with 10 mg OPC-28326 or with placebo, but none were serious or sustained. CONCLUSION: OPC-28326 at doses of 10 mg and 40 mg was well tolerated during this study. The shorter time to skin temperature recovery after 40 mg OPC-28326 suggests that selective alpha(2C)-AR blockade improves digital skin perfusion during recovery from cooling in patients with Raynaud's phenomenon secondary to scleroderma.

Administration, Oral↗