Angioedema in chronic spontaneous urticaria is underdiagnosed and has a substantial impact: Analyses from ASSURE-CSU.

BACKGROUND: ASSURE-CSU revealed differences in physician and patient reporting of angioedema. This post hoc analysis was conducted to evaluate the actual rate of angioedema in the study population and explore differences between patients with and without angioedema. METHODS: This international observational study assessed 673 patients with inadequately controlled chronic spontaneous urticaria (CSU). Physicians abstracted angioedema data from medical records, which were compared with patient-reported data. Patients in the Yes-angioedema category had angioedema reported in the medical record and a patient-reported source. For those in the No-angioedema category, angioedema was reported in neither the medical record nor a patient-reported source. Those in the Misaligned category had angioedema reported in only one source. Statistical comparisons between Yes-angioedema and No-angioedema categories were conducted for measures of CSU activity, health-related quality of life (HRQoL), productivity and healthcare resource utilization (HCRU). Regression analyses explored the relationship between Dermatology Life Quality Index (DLQI) score and angioedema, adjusting for important covariates. RESULTS: Among evaluable patients, 259 (40.3%), 173 (26.9%) and 211 (32.8%) were in the Yes-angioedema, No-angioedema and Misaligned category, respectively. CSU activity and impact on HRQoL, productivity, and HCRU was greater for Yes-angioedema patients than No-angioedema patients. After covariate adjustment, mean DLQI score was significantly higher (indicating worse HRQoL) for patients with angioedema versus no angioedema (9.88 vs 7.27, P < .001). The Misaligned category had similar results with Yes-angioedema on all outcomes. CONCLUSIONS: Angioedema in CSU seems to be under-reported but has significant negative impacts on HRQoL, daily activities, HCRU and work compared with no angioedema.

The burden of chronic spontaneous urticaria is substantial: Real-world evidence from ASSURE-CSU.

BACKGROUND: Chronic spontaneous urticaria (CSU) can be debilitating, difficult to treat, and frustrating for patients and physicians. Real-world evidence for the burden of CSU is limited. The objective of this study was to document disease duration, treatment history, and disease activity, as well as impact on health-related quality of life (HRQoL) and work among patients with inadequately controlled CSU, and to describe its humanistic, societal, and economic burden. METHODS: This international observational study assessed a cohort of 673 adult patients with CSU whose symptoms persisted for ≥12 months despite treatment. Demographics, disease characteristics, and healthcare resource use in the previous 12 months were collected from medical records. Patient-reported data on urticaria and angioedema symptoms, HRQoL, and work productivity and activity impairment were collected from a survey and a diary. RESULTS: Almost 50% of patients had moderate-to-severe disease activity as reported by Urticaria Activity Score. Mean (SD) Dermatology Life Quality Index and Chronic Urticaria Quality of Life Questionnaire scores were 9.1 (6.62) and 33.6 (20.99), respectively. Chronic spontaneous urticaria markedly interfered with sleep and daily activities. Angioedema in the previous 12 months was reported by 66% of enrolled patients and significantly affected HRQoL. More than 20% of patients reported ≥1 hour per week of missed work; productivity impairment was 27%. These effects increased with increasing disease activity. Significant healthcare resources and costs were incurred to treat CSU. CONCLUSIONS: Chronic spontaneous urticaria has considerable humanistic and economic impacts. Patients with greater disease activity and with angioedema experience greater HRQoL impairments.

The association between insurance status and prostate cancer outcomes: implications for the Affordable Care Act.

BACKGROUND: The Affordable Care Act (ACA) aims to expand health insurance coverage to over 30 million previously uninsured Americans. To help evaluate the potential impact of the ACA on prostate cancer care, we examined the associations between insurance coverage and prostate cancer outcomes among men <65 years old who are not yet eligible for Medicare. METHODS: The Surveillance, Epidemiology and End Results Program was used to identify 85 203 men aged <65 years diagnosed with prostate cancer from 2007 to 2010. Multivariable logistic regression modeled the association between insurance status and stage at presentation. Among men with high-risk disease, the associations between insurance status and receipt of definitive therapy, prostate cancer-specific mortality (PCSM) and all-cause mortality were determined using multivariable logistic, Fine and Gray competing-risks and Cox regression models, respectively. RESULTS: Uninsured patients were more likely to be non-white and come from regions of rural residence, lower median household income and lower education level (P<0.001 for all cases). Insured men were less likely to present with metastatic disease (adjusted odds ratio (AOR) 0.23; 95% confidence interval (CI) 0.20-0.27; P<0.001). Among men with high-risk disease, insured men were more likely to receive definitive treatment (AOR 2.29; 95% CI 1.81-2.89; P<0.001), and had decreased PCSM (adjusted hazard ratio 0.56; 95% CI 0.31-0.98; P=0.04) and all-cause mortality (adjusted hazard ratio 0.60; 0.39-0.91; P=0.01). CONCLUSIONS: Insured men with prostate cancer are less likely to present with metastatic disease, more likely to be treated if they develop high-risk disease and are more likely to survive their cancer, suggesting that expanding health coverage under the ACA may significantly improve outcomes for men with prostate cancer who are not yet eligible for Medicare.

Prevalence of opioid dispensings and concurrent gastrointestinal medications in Quebec.

BACKGROUND: Opioids are frequently prescribed for moderate to severe pain. A side effect of opioid usage is the inhibition of gastrointestinal (GI) motility, known as opioid-induced bowel dysfunction (OBD). OBD is typically treated prophylactically with laxatives and/or acid suppressants. AIM: The present study describes the prevalence of outpatient opioid dispensing, opioid patient demographics, and concomitant dispensing of opioids and GI medications in the Quebec Public Prescription Drug Insurance Plan in 2005. METHODS: Using a retrospective cohort design, opioid dispensings were identified using claims and reimbursement data. Laxative and acid suppressant dispensings were also identified. Concurrent use was defined as having at least one 'GI medication-exposed day' overlapping an 'opioid-exposed day'. RESULTS: More than 11% of the drug plan population was dispensed an opioid in 2005, and dispensings increased with age. Approximately two-thirds of patients who received an opioid were given codeine. Approximately one-third of opioid patients were concomitantly dispensed a GI medication, yet only 2% were dispensed a laxative. CONCLUSIONS: Although the GI side effects of opioids are well known, these side effects appear to increase with age and duration of opioid use. Opioid-related side effects, particularly OBD, should be effectively managed so as not to lead to the cessation of opioid therapy.

Research opportunities in palliative medicine.

Patients who require palliative care have many physical and psychosocial needs. Their families also require care and advice. Despite recent advances in assessment and management, major issues relating to palliative care for patients and their families remain unanswered. Several challenges face researchers in this area. We discuss administrative issues, including historical development, funding, academic recognition, integration of services, and cooperation among different centers. Methodological challenges in patient issues and trial design are outlined, and areas for future research are proposed.

Smokers' misperceptions of light and ultra-light cigarettes may keep them smoking.

INTRODUCTION: This study examined smokers' understanding of the relative tar deliveries of Ultra-light, Light, and Regular cigarettes, reasons for smoking Ultra-light/Light cigarettes, and the likelihood of both quitting smoking and switching to Regular cigarettes if they came to learn that one Ultra-light/Light cigarette gave the same amount of tar as one Regular cigarette. DESIGN: Ten- to fifteen-minute random-digit-dialed, computer-assisted telephone interviews (CATI) were conducted with both a national probability sample (n = 788) and a state random sample (n = 266) of daily smokers over the age of 18. RESULTS: Less than 10% of smokers in the national sample and only 14% of smokers in the state sample knew that one Light cigarette could give the same amount of tar as one Regular cigarette. Less than 10% of smokers in the state sample knew that one Ultra-light cigarette could give the same amount of tar as one Regular cigarette. Thirty-two percent of the Light and 26% of the Ultra-light smokers in the national sample, and 27% of Light and 25% of Ultra-light smokers in the state sample, said they would be likely to quit smoking if they learned one Light/Ultra-light equaled one Regular. CONCLUSION: Many Light and Ultra-light smokers are smoking these cigarettes to reduce the risks of smoking and/or as a step toward quitting. However, these smokers are unaware that one Ultra-light/Light cigarette can give them the same amount of tar and nicotine as one Regular cigarette. Many of the Ultra-light/Light smokers sampled in this study stated that they would be likely to quit if they knew this information. Mistaken beliefs about low-yield brands are reducing intentions to quit smoking.

1 of 3 pregnancies unwanted.

PIP: UNICEF's 1992 State of the World's Children Report observes that family planning is one of the most effective and least expensive ways of improving quality of life on earth. If all women were able to determine the size and spacing of their families, the report notes, there would be 1.3 billion fewer people in the world by the year 2025. A recent World Fertility Survey underscored the demand for family planning, pointing out that 1/3 of all pregnancies in the world are unwanted. Increased access to family planning services could go a long way toward decreasing maternal and child mortality and improving the quality of life for women and children. Family planning could save the lives of up to 1/3 of the 1/2 million women who die every year from pregnancy and birth related causes. Family planning could also prevent many of the 50,000 illegal abortions which are performed around the world every day, and could decrease the incidence of high risk pregnancies involving women under 18, over 35, or who already have more than 3 children. The report says that women who practice birth control have more time for education, earning income, child care, and leisure. And as parents are able to devote more time and resources to less children, the quality of child care rises. Unfortunately, as UNICEF executive director James P. Grant notes, the benefits of family planning have been obscured by controversy. But as recent experience has demonstrated, family planning can be promoted and practices in a way that is sensitive to the religion and culture of almost any society. The failure to realize the potential of family planning, the report says, is one of the greatest mistakes of our time.^ieng